{"id":17197,"date":"2021-03-01T21:42:49","date_gmt":"2021-03-01T21:42:49","guid":{"rendered":"https:\/\/www.tepsivo.com\/co-je-farmakovigilance\/"},"modified":"2026-06-05T20:37:38","modified_gmt":"2026-06-05T20:37:38","slug":"co-je-farmakovigilance","status":"publish","type":"page","link":"https:\/\/www.tepsivo.com\/cs\/co-je-farmakovigilance\/","title":{"rendered":"Co je farmakovigilance?"},"content":{"rendered":"\n[et_pb_section fb_built=“1″ custom_padding_last_edited=“on|phone“ next_background_color=“#ffffff“ admin_label=“Header“ _builder_version=“4.4.9″ background_color=“#EFF1F4″ background_image=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/IMG_No_style_20210303_193625_processed.jpg“ min_height=“350px“ custom_margin=“||0px||false|false“ custom_padding=“5vw||0vw||false|false“ custom_padding_tablet=“||||false|false“ custom_padding_phone=“||||false|false“ bottom_divider_style=“arrow2″ bottom_divider_height=“29px“ border_radii=“off|0px|0px|0px|“ global_colors_info=“{}“][\/et_pb_section][et_pb_section fb_built=“1″ custom_padding_last_edited=“on|phone“ admin_label=“Our Services“ _builder_version=“4.4.9″ use_background_color_gradient=“on“ background_color_gradient_start=“#ffffff“ background_color_gradient_end=“#eff1f4″ background_enable_image=“off“ min_height=“1081px“ custom_margin=“0px||0px||false|false“ custom_padding=“0px||0px|||“ custom_padding_tablet=““ custom_padding_phone=“0px||25px||false|false“ bottom_divider_style=“slant2″ bottom_divider_color=“#ffffff“ bottom_divider_height=“75px“ bottom_divider_arrangement=“below_content“ bottom_divider_height_tablet=““ bottom_divider_height_phone=“50px“ bottom_divider_height_last_edited=“on|phone“ global_colors_info=“{}“][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ module_alignment=“center“ custom_margin=“|-1px||-1px|false|false“ custom_padding=“37px|0px|13px|0px|false|false“ custom_padding_tablet=““ custom_padding_phone=“45px|0px|5px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Evropsk\u00e1 farmakovigilance<\/h2>\n

Na evropsk\u00e9 \u00farovni jsou pravidla a p\u0159edpisy pro farmakovigilanci slo\u017eit\u00e9 a jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 technick\u00e9 znalosti a efektivn\u00ed nadn\u00e1rodn\u00ed \u010dinnost ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Oboj\u00ed je na\u0161t\u011bst\u00ed na\u0161\u00ed specializac\u00ed a m\u016f\u017eeme v\u00e1s podpo\u0159it p\u0159i kompletn\u00edm zaji\u0161t\u011bn\u00ed syst\u00e9mu PV EU nebo jen jednotliv\u00fdch slu\u017eeb PV. <\/p>“ content_phone=“

Evropsk\u00e1 farmakovigilance<\/h2>\n

Na evropsk\u00e9 \u00farovni jsou pravidla a p\u0159edpisy pro farmakovigilanci slo\u017eit\u00e9 a jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 technick\u00e9 znalosti a efektivn\u00ed nadn\u00e1rodn\u00ed \u010dinnost ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Oboj\u00ed je na\u0161t\u011bst\u00ed na\u0161\u00ed specializac\u00ed a m\u016f\u017eeme v\u00e1s podpo\u0159it p\u0159i kompletn\u00edm zaji\u0161t\u011bn\u00ed syst\u00e9mu PV EU nebo jen jednotliv\u00fdch slu\u017eeb PV. <\/p>“ content_last_edited=“on|phone“ module_id=“eu-pharmacovigilance“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_text_color=“#312533″ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Montserrat|500|||||||“ header_3_text_color=“#7f7f7f“ header_3_font_size=“20px“ header_3_line_height=“1.6em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ custom_margin=“||8px||false|false“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“20px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Co je farmakovigilance?<\/h2>[\/et_pb_text][et_pb_text content_tablet=“

Evropsk\u00e1 farmakovigilance<\/h2>\n

Na evropsk\u00e9 \u00farovni jsou pravidla a p\u0159edpisy pro farmakovigilanci slo\u017eit\u00e9 a jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 technick\u00e9 znalosti a efektivn\u00ed nadn\u00e1rodn\u00ed \u010dinnost ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Oboj\u00ed je na\u0161t\u011bst\u00ed na\u0161\u00ed specializac\u00ed a m\u016f\u017eeme v\u00e1s podpo\u0159it p\u0159i kompletn\u00edm zaji\u0161t\u011bn\u00ed syst\u00e9mu PV EU nebo jen jednotliv\u00fdch slu\u017eeb PV. <\/p>“ content_phone=“

Evropsk\u00e1 farmakovigilance<\/h2>\n

Na evropsk\u00e9 \u00farovni jsou pravidla a p\u0159edpisy pro farmakovigilanci slo\u017eit\u00e9 a jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 technick\u00e9 znalosti a efektivn\u00ed nadn\u00e1rodn\u00ed \u010dinnost ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Oboj\u00ed je na\u0161t\u011bst\u00ed na\u0161\u00ed specializac\u00ed a m\u016f\u017eeme v\u00e1s podpo\u0159it p\u0159i kompletn\u00edm zaji\u0161t\u011bn\u00ed syst\u00e9mu PV EU nebo jen jednotliv\u00fdch slu\u017eeb PV. <\/p>“ content_last_edited=“on|phone“ module_id=“eu-pharmacovigilance“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_text_color=“#312533″ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Montserrat|500|||||||“ header_3_text_color=“#7f7f7f“ header_3_font_size=“20px“ header_3_line_height=“1.6em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ custom_margin=“||10px||false|false“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“20px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Popis knihy zn\u00ed takto:<\/span><\/p>[\/et_pb_text][et_pb_text content_tablet=“

Kdy m\u016f\u017eete pot\u0159ebovat na\u0161i pomoc?<\/span><\/h3>“ content_phone=“

Kdy m\u016f\u017eete pot\u0159ebovat na\u0161i pomoc?<\/span><\/h3>“ content_last_edited=“on|phone“ module_id=“eu-pharmacovigilance“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_text_color=“#312533″ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Montserrat|500|||||||“ header_3_text_align=“center“ header_3_text_color=“#7f7f7f“ header_3_font_size=“20px“ header_3_line_height=“2em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ max_width=“80%“ max_width_tablet=““ max_width_phone=“81%“ max_width_last_edited=“on|phone“ module_alignment=“center“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“20px“ header_3_font_size_last_edited=“on|phone“ module_alignment_tablet=““ module_alignment_phone=“center“ module_alignment_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

„V\u011bda a \u010dinnosti souvisej\u00edc\u00ed s odhalov\u00e1n\u00edm, hodnocen\u00edm, pochopen\u00edm a prevenc\u00ed ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f nebo jin\u00fdch probl\u00e9m\u016f souvisej\u00edc\u00edch s l\u00e9\u010divy.“<\/span><\/h3>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.4.9″ custom_margin_tablet=“||0px||false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||0px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ max_width=“100%“ module_alignment=“center“ global_colors_info=“{}“]

Once you read it, the sentence on its own probably doesn\u2019t tell you much about what your duties as a Marketing Authorization Holder (MAH) are. Tato str\u00e1nka v\u00e1m pom\u016f\u017ee pochopit, jak\u00e9 po\u017eadavky na farmakovigilanci (PV) mus\u00edte jako dr\u017eitel rozhodnut\u00ed o registraci (MAH) spl\u0148ovat, abyste byli v souladu s p\u0159edpisy a vyhnuli se probl\u00e9m\u016fm p\u0159i inspekc\u00edch. <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ background_color=“#ffffff“ custom_margin=“26px|auto|0px|auto|false|false“ custom_padding=“0px|60px|15px|60px|false|false“ custom_padding_tablet=““ custom_padding_phone=“0px|10%|0px|10%|false|false“ border_radii=“on|10px|10px|10px|10px“ box_shadow_style=“preset1″ box_shadow_vertical=“10px“ box_shadow_blur=“60px“ box_shadow_color=“rgba(1,33,92,0.1)“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“4.4.9″ custom_padding=“40px||10px||false|false“ custom_padding_tablet=“0px|||“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Funkce<\/h4>\n

Cloudov\u00e1 aplikace pro fotovoltaiku<\/p>\n

Ov\u011b\u0159eno<\/p>\n

P\u0159\u00edstupn\u00e9 z po\u010d\u00edta\u010de, telefonu nebo tabletu<\/p>\n

Pou\u017eit\u00ed automatiza\u010dn\u00edch n\u00e1stroj\u016f<\/p>\n

M\u00e1 kapacitu pro neomezen\u00e9 mno\u017estv\u00ed fotovoltaick\u00fdch dat<\/p>\n

Sleduje protokol auditu<\/p>\n

V souladu s GDPR<\/p>\n

Velmi intuitivn\u00ed a snadn\u00e1 navigace<\/p>\n

A dal\u0161\u00ed…<\/p>“ content_phone=“

Funkce<\/h4>\n

Cloudov\u00e1 aplikace pro fotovoltaiku<\/p>\n

\n

Ov\u011b\u0159eno<\/p>\n

\n

P\u0159\u00edstupn\u00e9 z po\u010d\u00edta\u010de, telefonu nebo tabletu<\/p>\n

\n

Pou\u017eit\u00ed automatiza\u010dn\u00edch n\u00e1stroj\u016f<\/p>\n

\n

M\u00e1 kapacitu pro neomezen\u00e9 mno\u017estv\u00ed fotovoltaick\u00fdch dat<\/p>\n

\n

Sleduje protokol auditu<\/p>\n

\n

V souladu s GDPR<\/p>\n

\n

Velmi intuitivn\u00ed a snadn\u00e1 navigace<\/p>\n

\n

A dal\u0161\u00ed…<\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Merriweather|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“Montserrat|||on|||||“ header_4_text_align=“center“ header_4_font_size=“20px“ header_4_line_height=“1.5em“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“justified“ max_width_tablet=“100%“ max_width_phone=““ max_width_last_edited=“on|tablet“ custom_margin_tablet=“35px||||false|false“ custom_margin_phone=“||-45px||false|false“ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||0px|||“ custom_padding_tablet=““ custom_padding_phone=“5px||0px||false|false“ custom_padding_last_edited=“on|phone“ header_2_font_size_tablet=““ header_2_font_size_phone=“20px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ text_orientation_tablet=“center“ text_orientation_phone=““ text_orientation_last_edited=“on|tablet“ module_alignment_tablet=“center“ module_alignment_phone=““ module_alignment_last_edited=“on|tablet“ locked=“off“ global_colors_info=“{}“]

This page is intended as a concise summary<\/strong> for those unfamiliar with the different EU and global PV requirements. Pokud se chcete do p\u0159edpis\u016f a legislativy pono\u0159it hloub\u011bji, ud\u011bl\u00e1te nejl\u00e9pe, kdy\u017e budete sledovat odkazy v pozn\u00e1mk\u00e1ch na konci. <\/p>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.4.9″ custom_padding=“40px||10px||false|false“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Benefit<\/h4>\n

Podstatn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu projektov\u00fdch FTE<\/p>\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita s ni\u017e\u0161\u00edm mno\u017estv\u00edm str\u00e1ven\u00e9ho \u010dasu<\/p>\n

Eliminuje nadbyte\u010dn\u00e9 sledovac\u00ed za\u0159\u00edzen\u00ed a kroky kontroly kvality.<\/p>\n

P\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase ke v\u0161em aktivit\u00e1m v oblasti fotovoltaiky ve va\u0161em projektu<\/p>\n

Automaticky generovan\u00e9 zpr\u00e1vy<\/p>\n

Pou\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu fotovoltaick\u00fdch slu\u017eeb<\/p>\n

Zv\u00fd\u0161en\u00e1 kvalita vstupn\u00edch fotovoltaick\u00fdch dat<\/p>\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 p\u0159ehledy projektov\u00fdch dat a statistik<\/p>\n

A dal\u0161\u00ed…<\/p>“ content_phone=“

Benefit<\/h4>\n

Podstatn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu projektov\u00fdch FTE<\/p>\n

\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita s ni\u017e\u0161\u00edm mno\u017estv\u00edm str\u00e1ven\u00e9ho \u010dasu<\/p>\n

\n

Eliminuje nadbyte\u010dn\u00e9 sledovac\u00ed za\u0159\u00edzen\u00ed a kroky kontroly kvality.<\/p>\n

\n

P\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase ke v\u0161em aktivit\u00e1m v oblasti fotovoltaiky ve va\u0161em projektu<\/p>\n

\n

Automaticky generovan\u00e9 zpr\u00e1vy<\/p>\n

\n

Pou\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu fotovoltaick\u00fdch slu\u017eeb<\/p>\n

\n

Zv\u00fd\u0161en\u00e1 kvalita vstupn\u00edch fotovoltaick\u00fdch dat<\/p>\n

\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 p\u0159ehledy projektov\u00fdch dat a statistik<\/p>\n

A dal\u0161\u00ed…<\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Merriweather|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“Montserrat|||on|||||“ header_4_text_align=“center“ header_4_font_size=“20px“ header_4_line_height=“1.5em“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“justified“ max_width_tablet=“85%“ max_width_phone=“100%“ max_width_last_edited=“on|tablet“ custom_margin_tablet=“-30px||||false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding_tablet=“0px||15px||false|false“ custom_padding_phone=“35px||||false|false“ custom_padding_last_edited=“on|tablet“ header_2_font_size_tablet=““ header_2_font_size_phone=“20px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ text_orientation_tablet=“center“ text_orientation_phone=““ text_orientation_last_edited=“on|tablet“ module_alignment_tablet=“center“ module_alignment_phone=““ module_alignment_last_edited=“on|tablet“ custom_css_main_element=“a {display:inline !important;}“ locked=“off“ global_colors_info=“{}“]

If you are a PV professional or are PV aware<\/strong>, you may find it more useful to learn about how we innovate and modernise the world of Pharmacovigilance: see pages Automation<\/a> or About us<\/a>.<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.4.9″ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.9″ global_colors_info=“{}“][et_pb_text content_tablet=“

Jak\u00e9 typy slu\u017eeb m\u016f\u017eeme nab\u00eddnout:<\/h3>\n

<\/p>“ content_phone=“

Jak\u00e9 typy slu\u017eeb m\u016f\u017eeme nab\u00eddnout:<\/h3>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Merriweather|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Montserrat|700|||||||“ header_3_text_color=“#7f7f7f“ header_3_font_size=“20px“ header_3_line_height=“1.6em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ custom_margin_tablet=“||0px||false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“9px|||||“ custom_padding_tablet=“9px||0px||false|false“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ header_2_font_size_tablet=““ header_2_font_size_phone=“20px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“20px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

N\u00e1\u0161 pr\u016fvodce se zab\u00fdv\u00e1 n\u00e1sleduj\u00edc\u00ed terminologi\u00ed v oblasti fotovoltaiky:<\/h3>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_3,1_3,1_3″ use_custom_gutter=“on“ gutter_width=“2″ custom_padding_last_edited=“on|tablet“ _builder_version=“4.4.9″ width=“100%“ width_tablet=““ width_phone=“85%“ width_last_edited=“on|phone“ max_width=“1045px“ module_alignment=“center“ custom_margin=“|0px||0px|false|false“ custom_padding=“14px|0px|29px|0px|false|false“ custom_padding_tablet=“0px|0px|29px|0px|false|false“ custom_padding_phone=““ global_colors_info=“{}“][et_pb_column type=“1_3″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“||||||||“ text_font_size=“15px“ text_line_height=“2em“ header_font=“||||||||“ header_3_font=“Poppins|600||on|||||“ header_3_font_size=“12px“ header_3_letter_spacing=“1px“ header_3_line_height=“1.6em“ header_4_font=“Montserrat|600||on|||||“ header_4_text_color=“#312533″ header_4_font_size=“14px“ header_4_line_height=“2em“ text_orientation=“right“ custom_margin=“15px||||false|false“ custom_padding=“0px|||||“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|tablet“ locked=“off“ global_colors_info=“{}“]

Farmakovigilan\u010dn\u00ed syst\u00e9m Master File (PSMF)<\/h4>[\/et_pb_text][et_pb_text _builder_version=“4.4.9″ text_font=“||||||||“ text_font_size=“15px“ text_line_height=“2em“ header_font=“||||||||“ header_3_font=“Poppins|600||on|||||“ header_3_font_size=“12px“ header_3_letter_spacing=“1px“ header_3_line_height=“1.6em“ header_4_font=“Montserrat|600||on|||||“ header_4_text_color=“#312533″ header_4_font_size=“14px“ header_4_line_height=“2em“ text_orientation=“right“ custom_padding=“0px|||||“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Pl\u00e1n \u0159\u00edzen\u00ed rizik<\/h4>[\/et_pb_text][et_pb_text _builder_version=“4.4.9″ text_font=“||||||||“ text_font_size=“15px“ text_line_height=“2em“ header_font=“||||||||“ header_3_font=“Poppins|600||on|||||“ header_3_font_size=“12px“ header_3_letter_spacing=“1px“ header_3_line_height=“1.6em“ header_4_font=“Montserrat|600||on|||||“ header_4_text_color=“#312533″ header_4_font_size=“14px“ text_orientation=“right“ custom_padding=“0px|||||“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Monitorov\u00e1n\u00ed literatury<\/h4>[\/et_pb_text][et_pb_text _builder_version=“4.4.9″ text_font=“||||||||“ text_font_size=“15px“ text_line_height=“2em“ header_font=“||||||||“ header_3_font=“Poppins|600||on|||||“ header_3_font_size=“12px“ header_3_letter_spacing=“1px“ header_3_line_height=“1.6em“ header_4_font=“Montserrat|600||on|||||“ header_4_text_color=“#312533″ header_4_font_size=“14px“ text_orientation=“right“ custom_padding=“0px|||||“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Spr\u00e1va sign\u00e1l\u016f<\/h4>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_3″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2020\/07\/t-tepsivo.png“ align=“center“ _builder_version=“4.4.9″ max_height=“177px“ max_height_tablet=“187px“ max_height_phone=“129px“ max_height_last_edited=“on|phone“ custom_padding=“27px||0px|||“ custom_padding_tablet=“10px||||false|false“ custom_padding_phone=“27px||27px||false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][et_pb_column type=“1_3″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

P\u0159ehl\u00eddka sv\u011btov\u00e9 a m\u00edstn\u00ed literatury<\/h4>“ content_phone=“

P\u0159ehl\u00eddka sv\u011btov\u00e9 a m\u00edstn\u00ed literatury<\/h4>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“||||||||“ text_font_size=“15px“ text_line_height=“2em“ header_font=“||||||||“ header_line_height=“1.3em“ header_3_font=“Poppins|600||on|||||“ header_3_font_size=“12px“ header_3_letter_spacing=“1px“ header_3_line_height=“1.6em“ header_4_font=“Montserrat|600||on|||||“ header_4_text_align=“left“ header_4_font_size=“14px“ header_4_line_height=“2em“ text_orientation=“right“ custom_margin=“15px||||false|false“ custom_padding=“0px|||||“ custom_padding_tablet=““ custom_padding_phone=“0px|27px||27px|false|true“ custom_padding_last_edited=“on|phone“ header_4_text_align_tablet=“center“ header_4_text_align_phone=““ header_4_text_align_last_edited=“on|tablet“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Kvalifikovan\u00e1 osoba Evropsk\u00e9 unie pro farmakovigilanci (EU QPPV)<\/h4>[\/et_pb_text][et_pb_text content_tablet=“

P\u0159\u00edprava z\u00e1kladn\u00edho souboru farmakovigilan\u010dn\u00edho syst\u00e9mu<\/h4>“ content_phone=“

P\u0159\u00edprava z\u00e1kladn\u00edho souboru farmakovigilan\u010dn\u00edho syst\u00e9mu<\/h4>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“||||||||“ text_font_size=“15px“ text_line_height=“2em“ header_font=“||||||||“ header_3_font=“Poppins|600||on|||||“ header_3_font_size=“12px“ header_3_letter_spacing=“1px“ header_3_line_height=“1.6em“ header_4_font=“Montserrat|600||on|||||“ header_4_text_align=“left“ header_4_text_color=“#312533″ header_4_font_size=“14px“ header_4_line_height=“2em“ text_orientation=“right“ custom_padding=“0px|||||“ header_4_text_align_tablet=“center“ header_4_text_align_phone=““ header_4_text_align_last_edited=“on|tablet“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

\u0158\u00cdZEN\u00cd ICSR<\/h4>[\/et_pb_text][et_pb_text content_tablet=“

Spr\u00e1va sign\u00e1l\u016f<\/h4>“ content_phone=“

Spr\u00e1va sign\u00e1l\u016f<\/h4>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_font_size=“15px“ text_line_height=“2em“ header_font=“||||||||“ header_text_align=“left“ header_3_font=“Poppins|600||on|||||“ header_3_font_size=“12px“ header_3_letter_spacing=“1px“ header_3_line_height=“1.6em“ header_4_font=“Montserrat|600||on|||||“ header_4_text_align=“left“ header_4_text_color=“#312533″ header_4_font_size=“14px“ header_4_line_height=“2em“ text_orientation=“center“ custom_padding=“0px|||||“ header_text_align_tablet=“center“ header_text_align_phone=““ header_text_align_last_edited=“on|tablet“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

M\u00edstn\u00ed kontaktn\u00ed osoba pro farmakovigilanci<\/h4>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.4.9″ min_height=“100px“ custom_padding=“||0px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Vztahuje se na v\u00e1s jin\u00e1 situace a nejste si jisti, jak\u00e9 jsou p\u0159esn\u011b va\u0161e regula\u010dn\u00ed a PV povinnosti?<\/p>\n

\u017d\u00e1dn\u00fd probl\u00e9m! Objednejte si u n\u00e1s bezplatnou 15minutovou konzultaci a spole\u010dn\u011b to vy\u0159e\u0161\u00edme.<\/a><\/p>“ content_phone=“

Vztahuje se na v\u00e1s jin\u00e1 situace a nejste si jisti, jak\u00e9 jsou p\u0159esn\u011b va\u0161e regula\u010dn\u00ed a PV povinnosti?<\/p>\n

\u017d\u00e1dn\u00fd probl\u00e9m!
Objednejte si u n\u00e1s bezplatnou 15minutovou konzultaci a spole\u010dn\u011b to vy\u0159e\u0161\u00edme.<\/a><\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_orientation=“center“ custom_margin_tablet=““ custom_margin_phone=“-15px||||false|false“ custom_margin_last_edited=“on|phone“ global_colors_info=“{}“]

Upozorn\u011bn\u00ed: N\u00ed\u017ee uveden\u00e9 informace slou\u017e\u00ed k bezplatn\u00e9mu informov\u00e1n\u00ed a vzd\u011bl\u00e1v\u00e1n\u00ed a je t\u0159eba je pova\u017eovat za rychl\u00fd referen\u010dn\u00ed bod a p\u0159ehled r\u016fzn\u00fdch povinnost\u00ed v oblasti fotovoltaiky, kter\u00e9 mus\u00ed MAH splnit. V \u017e\u00e1dn\u00e9m p\u0159\u00edpad\u011b by nem\u011bly b\u00fdt interpretov\u00e1ny jako odborn\u00e9 poradenstv\u00ed nebo \u00fapln\u00fd popis p\u0159\u00edslu\u0161n\u00fdch pr\u00e1vn\u00edch p\u0159edpis\u016f a pokyn\u016f. <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ custom_padding_last_edited=“on|tablet“ _builder_version=“4.4.9″ background_color=“#ffffff“ custom_padding=“25px||5px||false|false“ custom_padding_tablet=“10px||||false|false“ custom_padding_phone=““ global_colors_info=“{}“][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ module_alignment=“center“ custom_margin=“|-1px||-1px|false|false“ custom_padding=“1px|0px|1px|0px|true|false“ custom_padding_tablet=““ custom_padding_phone=“15px|0px|0px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Hlavn\u00ed soubor farmakovigilan\u010dn\u00edho syst\u00e9mu (PSMF)<\/h2>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ custom_padding_tablet=““ custom_padding_phone=“5px||||false|false“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“justified“ text_orientation_tablet=“center“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|tablet“ global_colors_info=“{}“]

You will probably have heard of this since you landed on a PV company website. Pharmacovigilance System Master File (PSMF) is the one guiding document defining your entire PV system in EU. It describes all processes and structures the MAH has in place to ensure compliance with GvP and EU legislation. Tento dokument budete muset pravideln\u011b udr\u017eovat a aktualizovat, abyste mohli zaji\u0161\u0165ovat sv\u00e9 PV \u010dinnosti, a na vy\u017e\u00e1d\u00e1n\u00ed jej mus\u00edte poskytnout regula\u010dn\u00edm org\u00e1n\u016fm k p\u0159ezkoum\u00e1n\u00ed. \n<\/p>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“justified“ text_orientation_tablet=“center“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|tablet“ global_colors_info=“{}“]

Kdy\u017e \u017e\u00e1d\u00e1te o registraci, mus\u00edte p\u0159edlo\u017eit souhrn PSMF. Nejlep\u0161\u00ed je sestavit tento dokument p\u0159ed pod\u00e1n\u00edm \u017e\u00e1dosti o registraci. Sou\u010d\u00e1st\u00ed souhrnu bude jm\u00e9no kvalifikovan\u00e9 osoby Evropsk\u00e9 unie pro farmakovigilanci. Obvykle se PSMF nach\u00e1z\u00ed v m\u00edst\u011b, kde s\u00eddl\u00ed kvalifikovan\u00e1 osoba EU pro farmakovigilanci (p\u0159\u00edpadn\u011b v m\u00edst\u011b, kde jsou prov\u00e1d\u011bny \u010dinnosti v oblasti PV). <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ custom_padding=“5px||10px||false|false“ custom_padding_tablet=““ custom_padding_phone=“||5px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“center“ global_colors_info=“{}“]

Do you need some help with putting the PSMF together? We\u2019re here for you. <\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ background_color=“#f4f5f7″ use_background_color_gradient=“on“ background_color_gradient_start=“#f4f5f7″ background_color_gradient_end=“#ffffff“ custom_margin=“1px||||false|false“ custom_padding=“34px||0px||false|false“ custom_padding_tablet=““ custom_padding_phone=“31px||45px||false|false“ top_divider_style=“slant2″ top_divider_color=“#ffffff“ top_divider_height=“75px“ top_divider_flip=“horizontal“ top_divider_height_tablet=““ top_divider_height_phone=“45px“ top_divider_height_last_edited=“on|phone“ bottom_divider_color=“#ffffff“ bottom_divider_height=“75px“ bottom_divider_height_tablet=““ bottom_divider_height_phone=“25px“ bottom_divider_height_last_edited=“on|phone“ global_colors_info=“{}“][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ module_alignment=“center“ custom_margin=“|-1px||-1px|false|false“ custom_padding=“49px|0px|10px|0px|false|false“ custom_padding_tablet=““ custom_padding_phone=“15px|0px|0px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Kvalifikovan\u00e1 osoba Evropsk\u00e9 unie pro farmakovigilanci (EU QPPV)<\/h2>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ _builder_version=“4.4.9″ custom_margin=“0px||||false|false“ custom_padding=“1px||1px||false|false“ locked=“off“ global_colors_info=“{}“ custom_css_main_element_last_edited=“on|tablet“ custom_css_main_element_tablet=“display: flex;“ custom_css_main_element_phone=“display: flex;“][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Merriweather|700|||||||“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ module_alignment=“center“ custom_padding=“15px|||0px|false|false“ custom_padding_tablet=“|15px|||false|false“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ header_4_font_size_phone=“20px“ header_4_font_size_last_edited=“off|desktop“ text_orientation_tablet=“justified“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“ custom_css_main_element_last_edited=“on|tablet“ custom_css_main_element_tablet=“display:flex;“ custom_css_main_element_phone=“display:flex;“]

Pokud pl\u00e1nujete nebo prod\u00e1v\u00e1te l\u00e9\u010div\u00fd p\u0159\u00edpravek v EU, budete pot\u0159ebovat zku\u0161en\u00e9ho odborn\u00edka na farmakovigilanci s dokonalou znalost\u00ed pokyn\u016f EMA a sm\u011brnic EU v oblasti farmakovigilance, kter\u00fd se ujme role kvalifikovan\u00e9 osoby pro farmakovigilanci. <\/p>

V podstat\u011b se jedn\u00e1 o hlavn\u00ed kontaktn\u00ed m\u00edsto regul\u00e1tora pro fotovoltaiku, jeho\u017e povinnost\u00ed je dohl\u00ed\u017eet na fotovoltaick\u00fd syst\u00e9m (jak je definov\u00e1n v PSMF) a samoz\u0159ejm\u011b poskytovat vstupn\u00ed informace t\u00fdkaj\u00edc\u00ed se bezpe\u010dnosti va\u0161ich v\u00fdrobk\u016f.<\/p>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Merriweather|700|||||||“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ module_alignment=“center“ custom_padding=“15px|||0px|false|false“ custom_padding_tablet=“|||15px|false|false“ custom_padding_phone=“0px|||0px|false|false“ custom_padding_last_edited=“on|phone“ header_4_font_size_phone=“20px“ header_4_font_size_last_edited=“off|desktop“ text_orientation_tablet=“justified“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ custom_css_main_element=“display: flex;“ locked=“off“ global_colors_info=“{}“]

Jm\u00e9no sv\u00e9 EU QPPV (kvalifikovan\u00e9 osoby odpov\u011bdn\u00e9 za farmakovigilanci v EU) mus\u00edte uv\u00e9st ji\u017e p\u0159i pod\u00e1v\u00e1n\u00ed \u017e\u00e1dosti o registraci; tato informace se poskytuje v p\u0159ehledu PSMF jako sou\u010d\u00e1st pod\u00e1n\u00ed. So, you should make sure you have the right person for the job before you submit the application.<\/p>

QPPV mus\u00ed b\u00fdt \u0159\u00e1dn\u011b kvalifikov\u00e1n v oblasti farmakovigilance, m\u00edt d\u016fkladnou znalost p\u0159edpis\u016f GvP a PV a mus\u00ed m\u00edt bydli\u0161t\u011b v EHP (v\u010detn\u011b Norska, Islandu a Lichten\u0161tejnska). <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ custom_padding=“34px||34px||true|“ custom_padding_tablet=““ custom_padding_phone=“||5px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“center“ global_colors_info=“{}“]

If you don\u2019t have the EU QPPV role covered in-house, you can easily sub-contract the position to Tepsivo and one of our QPPVs.<\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.4.9″ background_color=“#eff1f4″ custom_padding=“59px||44px|||“ top_divider_style=“slant2″ top_divider_color=“#ffffff“ top_divider_height=“75px“ top_divider_flip=“horizontal“ global_colors_info=“{}“][et_pb_row _builder_version=“4.4.3″ custom_padding=“41px||1px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_font_size=“35px“ header_2_font=“Montserrat|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ custom_margin_tablet=“15px||||false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Pl\u00e1n \u0159\u00edzen\u00ed rizik<\/h2>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/automatic-reporting-illustration.png“ title_text=“automatic-reporting-illustration“ align=“center“ _builder_version=“4.4.9″ module_alignment=“center“ max_height=“349px“ custom_padding=“21px||||false|false“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text content_tablet=“

Spole\u010dnost Tepsivo jsme zalo\u017eili s jasnou viz\u00ed: p\u0159em\u011bnit fotovoltaiku na modern\u00ed podnik. To bude mo\u017en\u00e9 pouze tehdy, pokud budeme vyu\u017e\u00edvat spr\u00e1vn\u00e9 n\u00e1stroje a postupy. V\u00fdznamnou roli v tom nepochybn\u011b sehraje automatizace, kterou m\u016f\u017eeme dos\u00e1hnout na\u0161eho ambici\u00f3zn\u00edho c\u00edle, pokud ji budeme spr\u00e1vn\u011b vyu\u017e\u00edvat, a teprve pak. <\/p>\n

Zat\u00edm pozorn\u011b sledujeme v\u00fdvoj automatizace mezi poskytovateli fotovoltaick\u00fdch slu\u017eeb a up\u0159\u00edmn\u011b \u0159e\u010deno, nejsme spokojeni. Je velmi m\u00f3dn\u00ed mluvit o v\u0161ech mo\u017enostech um\u011bl\u00e9 inteligence a omezen\u00ed manu\u00e1ln\u00ed pr\u00e1ce, ale kde jsou v\u00fdsledky? <\/p>

Jednoduch\u00e1 odpov\u011b\u010f pro tuto chv\u00edli m\u016f\u017ee b\u00fdt prost\u011b ta, \u017ee technologie na to je\u0161t\u011b nen\u00ed p\u0159ipravena. We may simply need to wait a little longer before we can process thousands of ICSRs with low manual labor and mundane and routine activities. While we wait, why not focus on what the modern technology can actually do today? That is what we do with our Tepsivo PV Application. <\/p>\n

<\/p>“ content_phone=“

Spole\u010dnost Tepsivo jsme zalo\u017eili s jasnou viz\u00ed: p\u0159em\u011bnit fotovoltaiku na modern\u00ed podnik. To bude mo\u017en\u00e9 pouze tehdy, pokud budeme vyu\u017e\u00edvat spr\u00e1vn\u00e9 n\u00e1stroje a postupy. V\u00fdznamnou roli v tom nepochybn\u011b sehraje automatizace, kterou m\u016f\u017eeme dos\u00e1hnout na\u0161eho ambici\u00f3zn\u00edho c\u00edle, pokud ji budeme spr\u00e1vn\u011b vyu\u017e\u00edvat, a teprve pak. <\/p>\n

Zat\u00edm pozorn\u011b sledujeme v\u00fdvoj automatizace mezi poskytovateli fotovoltaick\u00fdch slu\u017eeb a up\u0159\u00edmn\u011b \u0159e\u010deno, nejsme spokojeni. Je velmi m\u00f3dn\u00ed mluvit o v\u0161ech mo\u017enostech um\u011bl\u00e9 inteligence a omezen\u00ed manu\u00e1ln\u00ed pr\u00e1ce, ale kde jsou v\u00fdsledky? <\/p>

Jednoduchou odpov\u011bd\u00ed m\u016f\u017ee b\u00fdt, \u017ee technologie zat\u00edm nen\u00ed k dispozici. Mo\u017en\u00e1 budeme muset prost\u011b je\u0161t\u011b chv\u00edli po\u010dkat, ne\u017e budeme moci zpracov\u00e1vat tis\u00edce ICSR s mal\u00fdm pod\u00edlem ru\u010dn\u00ed pr\u00e1ce a v\u0161edn\u00edch a rutinn\u00edch \u010dinnost\u00ed. Zat\u00edmco budeme \u010dekat, pro\u010d se nesoust\u0159edit na to, co modern\u00ed technologie skute\u010dn\u011b um\u00ed u\u017e dnes? Pr\u00e1v\u011b to d\u011bl\u00e1me s na\u0161\u00ed aplikac\u00ed Tepsivo PV. <\/p>\n

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Side by side with the PSMF summary, a Risk Management Plan (RMP) needs to be submitted as part of your MA application dossier. As you can probably guess, the document should describe how risks are to be managed. Over the lifecycle of your product, the RMP needs to be updated either at the request of the EMA\/NCA or with new information that can significantly affect the product\u2019s safety profile.<\/p>\n

The RMP is a comprehensive document containing parts on the safety specification, pharmacovigilance plan, plans for post-authorization efficacy studies, and risk minimization measures. It takes expert knowledge and some time to put it together. <\/p>\n

Do you need help compiling the Risk Management Plan? We\u2019ll be happy to work on this with you.<\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ custom_padding_last_edited=“on|phone“ admin_label=“Services“ _builder_version=“4.4.9″ background_color=“#ffffff“ background_enable_image=“off“ background_position=“bottom_right“ background_blend=“multiply“ custom_margin=“||0px||false|false“ custom_margin_tablet=““ custom_margin_phone=“||0px||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“0vw||23px||false|false“ custom_padding_tablet=““ custom_padding_phone=“0vw||35px||false|false“ top_divider_style=“slant2″ top_divider_color=“#eff1f4″ top_divider_height=“75px“ top_divider_repeat=“0.75x“ saved_tabs=“all“ global_colors_info=“{}“][et_pb_row _builder_version=“4.4.9″ width_tablet=““ width_phone=“81%“ width_last_edited=“on|phone“ module_alignment=“center“ custom_margin=“|-1px||-1px|false|false“ custom_padding=“41px|0px|13px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.9″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=““ content_phone=“

M\u00edstn\u00ed kontaktn\u00ed osoba pro PV Globally<\/h2>\n

S\u00ed\u0165 m\u00edstn\u00edch kontaktn\u00edch osob pro fotovoltaiku (LCPPV), m\u00edstn\u00edch kvalifikovan\u00fdch osob pro fotovoltaiku (QPPV) nebo m\u00edstn\u00edch bezpe\u010dnostn\u00edch pracovn\u00edk\u016f (LSO) Tepsivo zahrnuje v\u0161echny sv\u011btov\u00e9 regiony a pokr\u00fdv\u00e1 v\u00edce ne\u017e 150 zem\u00ed.<\/p>

Pokud pot\u0159ebujete m\u00edstn\u00ed odborn\u00e9 znalosti v oblasti farmakovigilance, jsme tu pro v\u00e1s kdekoli na sv\u011bt\u011b.<\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“Montserrat||||||||“ header_text_color=“#312533″ header_font_size=“36px“ header_2_font=“Montserrat|700|||||||“ header_2_text_color=“#312533″ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ custom_padding=“20px||19px|||“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

\u0158\u00edzen\u00ed ICSR<\/h2>\n

Collection and reporting of side effects or potential side effects to the medicinal products on market is a key responsibility within Pharmacovigilance the MAHs have. Pro \u00fa\u010dely tohoto rychl\u00e9ho p\u0159ehledu tuto \u010dinnost zjednodu\u0161ujeme pod pojem zpracov\u00e1n\u00ed jednotliv\u00fdch hl\u00e1\u0161en\u00ed o bezpe\u010dnosti (ICSR Management), ale mezi ICSR, ne\u017e\u00e1douc\u00edmi p\u0159\u00edhodami, ne\u017e\u00e1douc\u00edmi \u00fa\u010dinky l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f nebo jin\u00fdmi podobn\u00fdmi hl\u00e1\u0161en\u00edmi existuj\u00ed rozd\u00edly. \n<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ custom_margin_tablet=““ custom_margin_phone=“||-41px||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“1px||30px|||“ custom_padding_tablet=““ custom_padding_phone=“1px||0px||false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|700|||||||“ header_4_text_color=“#7f7f7f“ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ max_width_tablet=““ max_width_phone=“95%“ max_width_last_edited=“on|phone“ module_alignment=“center“ custom_padding=“12px|||||“ custom_padding_tablet=““ custom_padding_phone=“12px|0px||0px|false|true“ custom_padding_last_edited=“on|phone“ header_4_text_align_tablet=“center“ header_4_text_align_phone=““ header_4_text_align_last_edited=“on|tablet“ header_4_font_size_phone=“20px“ header_4_font_size_last_edited=“off|desktop“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Basically, you need to ensure you have a good system in place to capture all suspected adverse reactions, store it, validate as an ICSR, and submit to EMA and other regulatory agencies. Zdroje mohou b\u00fdt r\u016fzn\u00e9, p\u0159i\u010dem\u017e se rozli\u0161uj\u00ed p\u0159edev\u0161\u00edm hl\u00e1\u0161en\u00ed spont\u00e1nn\u00ed (nevy\u017e\u00e1dan\u00e1) a vy\u017e\u00e1dan\u00e1. <\/p>\n

Typick\u00fdmi zdroji nevy\u017e\u00e1dan\u00fdch zpr\u00e1v mohou b\u00fdt spot\u0159ebitel\u00e9 komunikuj\u00edc\u00ed prost\u0159ednictv\u00edm l\u00e9ka\u0159sk\u00fdch dotaz\u016f (webov\u00e9 str\u00e1nky, telefon…), z\u00e1stupci spole\u010dnost\u00ed, zdravotn\u00edci, soci\u00e1ln\u00ed m\u00e9dia (a kdekoli na internetu), odborn\u00e1 literatura (viz n\u00ed\u017ee) a mnoho dal\u0161\u00edch p\u0159\u00edle\u017eitostn\u00fdch zdroj\u016f odkudkoli, kde si vzpomenete. <\/p>\n

Vy\u017e\u00e1dan\u00e1 hl\u00e1\u0161en\u00ed poch\u00e1zej\u00ed obvykle z program\u016f organizovan\u00e9ho sb\u011bru dat, jako jsou klinick\u00e9 studie, neinterven\u010dn\u00ed studie, programy pro jmenovit\u00e9 pou\u017eit\u00ed pacienty, soucitn\u00e9 pou\u017eit\u00ed, pr\u016fzkumy a dal\u0161\u00ed podobn\u00e9 syst\u00e9my.<\/p>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/telehealth-25.png“ title_text=“telehealth-25″ align=“center“ _builder_version=“4.4.9″ max_height=“365px“ custom_padding=“15px||||false|false“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ admin_label=“\u0158\u00e1dek“ _builder_version=“4.4.9″ custom_margin_tablet=“0px||||false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||36px||false|false“ module_alignment_tablet=“center“ module_alignment_phone=““ module_alignment_last_edited=“on|tablet“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/telehealth-23.png“ title_text=“telehealth-23″ align=“center“ _builder_version=“4.4.9″ module_alignment=“center“ max_height=“370px“ custom_padding=“57px||||false|false“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

A dodr\u017eujete p\u0159edpisy?<\/h4>\n

M\u00edstn\u00ed po\u017eadavky na fotovoltaiku jsou nejen slo\u017eit\u00e9 na orientaci, ale tak\u00e9 se \u010das od \u010dasu m\u011bn\u00ed. D\u016fkladn\u00e1 znalost glob\u00e1ln\u00edch p\u0159edpis\u016f je kl\u00ed\u010dov\u00e1. Pe\u010dliv\u011b sledujeme v\u0161echny n\u00e1rodn\u00ed agentury a pr\u016fb\u011b\u017en\u011b informujeme o v\u0161ech zm\u011bn\u00e1ch. Db\u00e1me na to, aby o nich na\u0161i klienti m\u011bli v\u017edy p\u0159ehled a mohli v\u010das reagovat na p\u0159\u00edpadn\u00fd nov\u00fd legislativn\u00ed v\u00fdvoj. <\/p>\n

Chcete se dozv\u011bd\u011bt v\u00edce?
Objednejte si bezplatnou 15minutovou konzultaci.<\/a><\/p>“ content_phone=“

A dodr\u017eujete p\u0159edpisy?<\/h4>\n

M\u00edstn\u00ed po\u017eadavky na fotovoltaiku jsou nejen slo\u017eit\u00e9 na orientaci, ale tak\u00e9 se \u010das od \u010dasu m\u011bn\u00ed. D\u016fkladn\u00e1 znalost glob\u00e1ln\u00edch p\u0159edpis\u016f je kl\u00ed\u010dov\u00e1. Pe\u010dliv\u011b sledujeme v\u0161echny n\u00e1rodn\u00ed agentury a pr\u016fb\u011b\u017en\u011b informujeme o v\u0161ech zm\u011bn\u00e1ch. Db\u00e1me na to, aby o nich na\u0161i klienti m\u011bli v\u017edy p\u0159ehled a mohli v\u010das reagovat na p\u0159\u00edpadn\u00fd nov\u00fd legislativn\u00ed v\u00fdvoj. <\/p>\n

Chcete se dozv\u011bd\u011bt v\u00edce?
Objednejte si bezplatnou 15minutovou konzultaci.<\/a><\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|700|||||||“ header_4_text_color=“#7f7f7f“ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ module_alignment=“center“ custom_margin=“5px||||false|false“ custom_padding=“22px|||||“ custom_padding_tablet=“0px||||false|false“ custom_padding_phone=“0px||||false|false“ custom_padding_last_edited=“on|phone“ header_text_align_tablet=“center“ header_text_align_phone=““ header_text_align_last_edited=“on|tablet“ header_4_font_size_phone=“20px“ header_4_font_size_last_edited=“off|desktop“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Co se tedy stane, kdy\u017e se objev\u00ed podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek, kter\u00fd m\u016f\u017ee souviset s va\u0161\u00edm v\u00fdrobkem? Mus\u00edte ji ov\u011b\u0159it jako ICSR a zjistit, zda se skute\u010dn\u011b jedn\u00e1 o reakci, kter\u00e1 m\u00e1 p\u0159\u00ed\u010dinnou souvislost s v\u00fdrobkem. Je to trochu slo\u017eit\u011bj\u0161\u00ed, ale zjednodu\u0161en\u011b \u0159e\u010deno, hl\u00e1\u0161en\u00ed mus\u00ed spl\u0148ovat 4 minim\u00e1ln\u00ed krit\u00e9ria: identifikovateln\u00fd oznamovatel(\u00e9), identifikovateln\u00fd pacient, podez\u0159el\u00e1(\u00e9) l\u00e1tka(y)\/v\u00fdrobek(y) a podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek(y). <\/p>\n

A\u017e bude ICSR potvrzena, mus\u00ed se o tom ve\u0159ejnost dozv\u011bd\u011bt. ICSR byste m\u011bli p\u0159edlo\u017eit EMA (konkr\u00e9tn\u011b do EudraVigilance, datab\u00e1ze EU o podez\u0159en\u00edch na ne\u017e\u00e1douc\u00ed \u00fa\u010dinky) a dal\u0161\u00edm regula\u010dn\u00edm org\u00e1n\u016fm v z\u00e1vislosti na zem\u011bpisn\u00e9 poloze. <\/p>\n

Mus\u00edte tak\u00e9 zajistit, abyste vedli z\u00e1znamy o zpr\u00e1v\u00e1ch ICSR a dal\u0161\u00edch zpr\u00e1v\u00e1ch, kter\u00e9 v\u00e1m p\u0159ijdou. Syst\u00e9my PV obvykle pou\u017e\u00edvaj\u00ed „bezpe\u010dnostn\u00ed datab\u00e1zi“ pro \u0159\u00edzen\u00ed celkov\u00fdch \u010dinnost\u00ed spr\u00e1vy ICSR, od okam\u017eiku p\u0159\u00edchodu hl\u00e1\u0161en\u00ed a\u017e po jeho p\u0159edlo\u017een\u00ed regula\u010dn\u00edm org\u00e1n\u016fm. <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.4.3″ custom_padding=“10px||16px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“Montserrat||||||||“ text_orientation=“center“ global_colors_info=“{}“]

The ICSR management can easily become the most time-consuming activity of all your PV processes. You will do best to use a system that can streamline the entire process and shave off as much unnecessary workload as possible. Yes, we can help\u2026 Reach out.<\/span><\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.4.9″ use_background_color_gradient=“on“ background_color_gradient_start=“#eff1f4″ background_color_gradient_end=“#ffffff“ custom_margin=“0px||||false|false“ custom_margin_tablet=“0px||||false|false“ custom_margin_phone=“0px||||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“||3px||false|false“ top_divider_style=“slant2″ top_divider_color=“#ffffff“ top_divider_height=“75px“ top_divider_flip=“vertical“ bottom_divider_color=“#ffffff“ global_colors_info=“{}“][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ module_alignment=“center“ custom_margin=“|-1px||-1px|false|false“ custom_margin_tablet=““ custom_margin_phone=““ custom_margin_last_edited=“on|phone“ custom_padding=“34px|0px|13px|0px|false|false“ custom_padding_tablet=“65px||||false|false“ custom_padding_phone=“35px|0px|13px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Prom\u00edt\u00e1n\u00ed literatury<\/h2>\n

Scientific journals are important sources of Adverse Drug Reaction reports and other safety relevant information. V\u00fdrobc\u016fm l\u00e9k\u016f je na\u0159\u00edzeno zajistit d\u016fkladn\u00fd a pravideln\u00fd screening p\u0159\u00edslu\u0161n\u00e9 literatury. <\/p>

V z\u00e1vislosti na pokryt\u00ed va\u0161eho trhu budete muset prov\u00e1d\u011bt monitorov\u00e1n\u00ed v glob\u00e1ln\u00edch datab\u00e1z\u00edch, jako je PubMed nebo Embase, ale tak\u00e9 se mo\u017en\u00e1 budete muset bl\u00ed\u017ee pod\u00edvat na neindexovan\u00e9 \u010dasopisy v m\u00edstn\u00edch jazyc\u00edch na va\u0161ich trz\u00edch. Je zapot\u0159eb\u00ed jak glob\u00e1ln\u00edch, tak m\u00edstn\u00edch odborn\u00fdch znalost\u00ed v oblasti PV, a pr\u00e1v\u011b v tom v\u00e1m m\u016f\u017eeme pomoci. <\/p>“ content_phone=““ content_last_edited=“on|tablet“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“Montserrat||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_text_color=“#312533″ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ max_width_tablet=““ max_width_phone=““ max_width_last_edited=“on|tablet“ custom_margin=“0px||||false|false“ custom_margin_tablet=“0px|0px||0px|false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||||false|false“ custom_padding_tablet=“|0px||0px|false|false“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Monitorov\u00e1n\u00ed literatury<\/h2>\n

Jakmile po\u017e\u00e1d\u00e1te o registraci (Marketing Authorization), m\u00e1te povinnost pravideln\u011b a \u010dasto sledovat v\u011bdeckou literaturu, abyste zachytili jak\u00e9koli potenci\u00e1ln\u00ed informace relevantn\u00ed pro bezpe\u010dnost. Scientific literature is an important source of possible adverse reactions and so it takes a crucial part of the overall PV process. Tento proces m\u016f\u017eeme v z\u00e1sad\u011b rozd\u011blit do dvou hlavn\u00edch \u010d\u00e1st\u00ed: glob\u00e1ln\u00ed a lok\u00e1ln\u00ed screening literatury. <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ _builder_version=“3.25″ custom_padding=“7px||1px|||“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#7f7f7f“ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ module_alignment=“center“ custom_padding=“36px|||48px|false|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=“15px|||0px|false|false“ custom_padding_last_edited=“on|phone“ header_4_font_size_phone=“20px“ header_4_font_size_last_edited=“off|desktop“ text_orientation_tablet=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Pro tzv. glob\u00e1ln\u00ed sledov\u00e1n\u00ed literatury byste m\u011bli jako MAH systematicky proch\u00e1zet publikace v \u0161iroce pou\u017e\u00edvan\u00fdch datab\u00e1z\u00edch, jako je Medline nebo Embase; sta\u010d\u00ed jednou t\u00fddn\u011b. Pokud se zjist\u00ed p\u0159\u00ed\u010dinn\u00e1 souvislost mezi dan\u00fdm l\u00e9\u010divem a podez\u0159en\u00edm na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek, je t\u0159eba posoudit p\u0159\u00edslu\u0161n\u00fd \u010dl\u00e1nek a zpracovat p\u0159\u00edpadn\u00e9 individu\u00e1ln\u00ed hl\u00e1\u0161en\u00ed o bezpe\u010dnostn\u00edm p\u0159\u00edpadu. <\/p>\n

To, \u010demu \u0159\u00edk\u00e1me screening m\u00edstn\u00ed literatury, je trochu slo\u017eit\u011bj\u0161\u00ed. V ka\u017ed\u00e9 zemi, kde je v\u00e1\u0161 produkt autorizov\u00e1n, byste m\u011bli d\u016fkladn\u011b sledovat v\u0161echny \u010dasopisy v m\u00edstn\u00edm jazyce, na kter\u00e9 se neodkazuje v „glob\u00e1ln\u00edch“ datab\u00e1z\u00edch. Je jasn\u00e9, \u017ee k tomu budete pot\u0159ebovat m\u00edstn\u00edho odborn\u00edka na PV se znalost\u00ed m\u00edstn\u00edho jazyka a samoz\u0159ejm\u011b i p\u0159\u00edslu\u0161n\u00fdch v\u011bdeck\u00fdch \u010dasopis\u016f v dan\u00e9 zemi. <\/p>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2020\/07\/literature-screening-1.png“ show_bottom_space=“off“ align_tablet=“center“ align_phone=“center“ align_last_edited=“on|phone“ _builder_version=“4.4.9″ max_width_tablet=“49%“ max_width_phone=““ max_width_last_edited=“on|tablet“ max_height=“330px“ max_height_tablet=“307px“ max_height_phone=“293px“ max_height_last_edited=“on|phone“ custom_margin=“32px|||||“ custom_margin_tablet=“0px|0px|0px|0px|false|false“ custom_margin_phone=“-15px||0px||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“4px||17px|102px|false|false“ custom_padding_tablet=“0px|0px|0px|0px|false|false“ custom_padding_phone=“0px||0px|4px|false|false“ custom_padding_last_edited=“on|phone“ module_alignment_tablet=“center“ module_alignment_phone=“center“ module_alignment_last_edited=“on|phone“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ custom_padding=“39px||0px|||“ custom_padding_tablet=“47px||||false|false“ custom_padding_phone=“30px||5px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Merriweather|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ custom_padding=“||12px|||“ header_2_font_size_tablet=““ header_2_font_size_phone=“20px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Literature Monitoring can be a time-consuming activity and you will do best to adapt digital solutions to help ease the process. If you are present across global markets and need local PV support with the medicinal journals, the Tepsivo network of local PV experts across 150+ countries may just be the right solution. Reach out to us and see how we can take care of your literature duties.<\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ custom_padding_last_edited=“on|tablet“ prev_background_color=“#ffffff“ _builder_version=“4.4.9″ background_color=“#eff1f4″ custom_padding=“108px||46px|||“ custom_padding_tablet=“10px||||false|false“ custom_padding_phone=““ top_divider_style=“slant2″ top_divider_height=“75px“ global_colors_info=“{}“][et_pb_row _builder_version=“4.4.3″ custom_margin=“0px|auto|23px|auto|false|false“ custom_padding=“0px||0px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

M\u00edstn\u00ed kontaktn\u00ed osoba pro farmakovigilanci (LCPPV)<\/h2>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ custom_padding_last_edited=“on|tablet“ _builder_version=“4.4.9″ custom_margin_tablet=“0px||0px||false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“1px||24px|||“ custom_padding_tablet=“1px||0px||false|false“ custom_padding_phone=““ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Na\u0161e aplikace PV eliminuje ve\u0161kerou zbyte\u010dnou pr\u00e1ci spr\u00e1vce pomoc\u00ed automatick\u00fdch p\u0159\u00edkaz\u016f. Zaji\u0161\u0165uje vysokou kvalitu vstupn\u00edch dat, jako jsou zpr\u00e1vy ADR (a dal\u0161\u00ed) s p\u0159eddefinovan\u00fdmi poli, kter\u00e9 m\u016f\u017eete propojit s vlastn\u00ed datab\u00e1z\u00ed. Ke v\u0161em dat\u016fm budete m\u00edt p\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase a navrch si m\u016f\u017eete prohl\u00ed\u017eet dashboardy s kl\u00ed\u010dov\u00fdmi p\u0159ehledy. <\/p>\n

Ch\u00e1peme, \u017ee ka\u017ed\u00fd z na\u0161ich klient\u016f m\u00e1 specifick\u00e9 po\u017eadavky a pot\u0159eby. Na\u0161e aplikace pro v\u00e1s m\u016f\u017ee fungovat jen s ur\u010dit\u00fdmi \u00fapravami, a to je v po\u0159\u00e1dku. Aplikace je konfigurovateln\u00e1 a jej\u00ed funkce m\u016f\u017eeme p\u0159izp\u016fsobit speci\u00e1ln\u011b pro v\u00e1s. Koneckonc\u016f \u017e\u00e1dn\u00ed dva na\u0161i klienti nemaj\u00ed \u00fapln\u011b stejnou aplikaci. <\/p>“ content_phone=“

Na\u0161e aplikace PV eliminuje ve\u0161kerou zbyte\u010dnou pr\u00e1ci spr\u00e1vce pomoc\u00ed automatick\u00fdch p\u0159\u00edkaz\u016f. Zaji\u0161\u0165uje vysokou kvalitu vstupn\u00edch dat, jako jsou zpr\u00e1vy ADR (a dal\u0161\u00ed) s p\u0159eddefinovan\u00fdmi poli, kter\u00e9 m\u016f\u017eete propojit s vlastn\u00ed datab\u00e1z\u00ed. Ke v\u0161em dat\u016fm budete m\u00edt p\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase a navrch si m\u016f\u017eete prohl\u00ed\u017eet dashboardy s kl\u00ed\u010dov\u00fdmi p\u0159ehledy. <\/p>\n

Ch\u00e1peme, \u017ee ka\u017ed\u00fd z na\u0161ich klient\u016f m\u00e1 specifick\u00e9 po\u017eadavky a pot\u0159eby. Na\u0161e aplikace pro v\u00e1s m\u016f\u017ee fungovat jen s ur\u010dit\u00fdmi \u00fapravami, a to je v po\u0159\u00e1dku. Aplikace je konfigurovateln\u00e1 a jej\u00ed funkce m\u016f\u017eeme p\u0159izp\u016fsobit speci\u00e1ln\u011b pro v\u00e1s. Koneckonc\u016f \u017e\u00e1dn\u00ed dva na\u0161i klienti nemaj\u00ed \u00fapln\u011b stejnou aplikaci. <\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Merriweather|700|||||||“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ module_alignment=“center“ custom_padding=“12px|||||“ custom_padding_tablet=““ custom_padding_phone=“0px||||false|false“ custom_padding_last_edited=“on|phone“ header_4_font_size_phone=“20px“ header_4_font_size_last_edited=“off|desktop“ text_orientation_tablet=“center“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Povinnost kontroly m\u00edstn\u00ed literatury v ka\u017ed\u00e9 zemi, kde je v\u00e1\u0161 v\u00fdrobek schv\u00e1len, nen\u00ed jedinou povinnost\u00ed, kterou jako glob\u00e1ln\u00ed organizace m\u00e1te. N\u011bkolik zem\u00ed EU a mnoho dal\u0161\u00edch zem\u00ed po cel\u00e9m sv\u011bt\u011b vy\u017eaduje jmenov\u00e1n\u00ed m\u00edstn\u00ed kontaktn\u00ed osoby pro farmakovigilanci (LCPPV). N\u011bkdy se terminologie li\u0161\u00ed, m\u016f\u017ee j\u00edt o Local QPPV, Local Safety Officer nebo jin\u00fd n\u00e1zev; v\u0161echno to v\u00edcem\u00e9n\u011b znamen\u00e1 tot\u00e9\u017e. \n<\/p>\n

A Local Contact Person for PV takes on a similar role as the EU QPPV, but logically has that responsibility locally in their country. This should be the key contact point between you and the respective National Competent Authority regulating your product(s) locally. M\u011bli by ovl\u00e1dat m\u00edstn\u00ed jazyk, pob\u00fdvat v dan\u00e9 zemi (co\u017e nen\u00ed v\u017edy nutn\u00e9) a dokonale zn\u00e1t PV p\u0159edpisy ve sv\u00e9 zemi. \n<\/p>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/telehealth-18.png“ title_text=“telehealth-18″ align=“center“ _builder_version=“4.4.9″ max_height=“357px“ custom_padding=“25px||||false|false“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ background_color=“#ffffff“ custom_margin=“26px|auto|0px|auto|false|false“ custom_padding=“0px|60px|15px|60px|false|false“ custom_padding_tablet=““ custom_padding_phone=“0px|10%|0px|10%|false|false“ border_radii=“on|10px|10px|10px|10px“ box_shadow_style=“preset1″ box_shadow_vertical=“10px“ box_shadow_blur=“60px“ box_shadow_color=“rgba(1,33,92,0.1)“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“4.4.9″ custom_padding=“40px||10px||false|false“ custom_padding_tablet=“0px|||“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Funkce<\/h4>\n

Cloudov\u00e1 aplikace pro fotovoltaiku<\/p>\n

Ov\u011b\u0159eno<\/p>\n

P\u0159\u00edstupn\u00e9 z po\u010d\u00edta\u010de, telefonu nebo tabletu<\/p>\n

Pou\u017eit\u00ed automatiza\u010dn\u00edch n\u00e1stroj\u016f<\/p>\n

M\u00e1 kapacitu pro neomezen\u00e9 mno\u017estv\u00ed fotovoltaick\u00fdch dat<\/p>\n

Sleduje protokol auditu<\/p>\n

V souladu s GDPR<\/p>\n

Velmi intuitivn\u00ed a snadn\u00e1 navigace<\/p>\n

A dal\u0161\u00ed…<\/p>“ content_phone=“

Funkce<\/h4>\n

Cloudov\u00e1 aplikace pro fotovoltaiku<\/p>\n

\n

Ov\u011b\u0159eno<\/p>\n

\n

P\u0159\u00edstupn\u00e9 z po\u010d\u00edta\u010de, telefonu nebo tabletu<\/p>\n

\n

Pou\u017eit\u00ed automatiza\u010dn\u00edch n\u00e1stroj\u016f<\/p>\n

\n

M\u00e1 kapacitu pro neomezen\u00e9 mno\u017estv\u00ed fotovoltaick\u00fdch dat<\/p>\n

\n

Sleduje protokol auditu<\/p>\n

\n

V souladu s GDPR<\/p>\n

\n

Velmi intuitivn\u00ed a snadn\u00e1 navigace<\/p>\n

\n

A dal\u0161\u00ed…<\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Merriweather|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“Montserrat|||on|||||“ header_4_text_align=“center“ header_4_font_size=“20px“ header_4_line_height=“1.5em“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“justified“ max_width_tablet=“100%“ max_width_phone=““ max_width_last_edited=“on|tablet“ custom_margin_tablet=“35px||||false|false“ custom_margin_phone=“||-45px||false|false“ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||0px|||“ custom_padding_tablet=““ custom_padding_phone=“5px||0px||false|false“ custom_padding_last_edited=“on|phone“ header_2_font_size_tablet=““ header_2_font_size_phone=“20px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ text_orientation_tablet=“center“ text_orientation_phone=““ text_orientation_last_edited=“on|tablet“ module_alignment_tablet=“center“ module_alignment_phone=““ module_alignment_last_edited=“on|tablet“ locked=“off“ global_colors_info=“{}“]

Don\u2019t worry, you don\u2019t need to start hiring employees everywhere around the world.<\/strong> We can appoint a LCPPV in 150+ countries of the world on your behalf. <\/p>

What is more? We can manage the full global operations in a completely automated way via our in-house services delivery platform, where we can also look after your internal resources at your affiliates. Don\u2019t be surprised if you can\u2019t compare this offer to other solutions, we\u2019re the only ones doing it this way. <\/p>

Just contact us and we can provide this to you.<\/a><\/p>.[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.4.9″ custom_padding=“40px||10px||false|false“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Benefit<\/h4>\n

Podstatn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu projektov\u00fdch FTE<\/p>\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita s ni\u017e\u0161\u00edm mno\u017estv\u00edm str\u00e1ven\u00e9ho \u010dasu<\/p>\n

Eliminuje nadbyte\u010dn\u00e9 sledovac\u00ed za\u0159\u00edzen\u00ed a kroky kontroly kvality.<\/p>\n

P\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase ke v\u0161em aktivit\u00e1m v oblasti fotovoltaiky ve va\u0161em projektu<\/p>\n

Automaticky generovan\u00e9 zpr\u00e1vy<\/p>\n

Pou\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu fotovoltaick\u00fdch slu\u017eeb<\/p>\n

Zv\u00fd\u0161en\u00e1 kvalita vstupn\u00edch fotovoltaick\u00fdch dat<\/p>\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 p\u0159ehledy projektov\u00fdch dat a statistik<\/p>\n

A dal\u0161\u00ed…<\/p>“ content_phone=“

Benefit<\/h4>\n

Podstatn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu projektov\u00fdch FTE<\/p>\n

\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita s ni\u017e\u0161\u00edm mno\u017estv\u00edm str\u00e1ven\u00e9ho \u010dasu<\/p>\n

\n

Eliminuje nadbyte\u010dn\u00e9 sledovac\u00ed za\u0159\u00edzen\u00ed a kroky kontroly kvality.<\/p>\n

\n

P\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase ke v\u0161em aktivit\u00e1m v oblasti fotovoltaiky ve va\u0161em projektu<\/p>\n

\n

Automaticky generovan\u00e9 zpr\u00e1vy<\/p>\n

\n

Pou\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu fotovoltaick\u00fdch slu\u017eeb<\/p>\n

\n

Zv\u00fd\u0161en\u00e1 kvalita vstupn\u00edch fotovoltaick\u00fdch dat<\/p>\n

\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 p\u0159ehledy projektov\u00fdch dat a statistik<\/p>\n

A dal\u0161\u00ed…<\/p>“ content_last_edited=“on|phone“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Merriweather|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“Montserrat|||on|||||“ header_4_text_align=“center“ header_4_font_size=“20px“ header_4_line_height=“1.5em“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“justified“ max_width_tablet=“85%“ max_width_phone=“100%“ max_width_last_edited=“on|tablet“ custom_margin_tablet=“-30px||||false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding_tablet=“0px||15px||false|false“ custom_padding_phone=“35px||||false|false“ custom_padding_last_edited=“on|tablet“ header_2_font_size_tablet=““ header_2_font_size_phone=“20px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ text_orientation_tablet=“center“ text_orientation_phone=““ text_orientation_last_edited=“on|tablet“ module_alignment_tablet=“center“ module_alignment_phone=““ module_alignment_last_edited=“on|tablet“ custom_css_main_element=“a {display:inline !important;}“ locked=“off“ global_colors_info=“{}“]

Furthermore, in some countries, the LCPPV role is legally required.<\/strong> In other countries, it\u2019s simply good practice to have someone in country responsible for PV in that market.<\/p>

The requirements on this role and their responsibilities also differ country by country. If you don\u2019t want your head spinning having to figure what exactly you need to do and where, you should take advantage of a concise regulatory intelligence reporting, using data from all competent authorities.<\/p>

See our page about Automation<\/a> or reach out<\/a>.<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ admin_label=“Our Services“ _builder_version=“4.4.9″ background_enable_color=“off“ use_background_color_gradient=“on“ background_color_gradient_start=“#ffffff“ background_color_gradient_end=“#f4f5f7″ background_enable_image=“off“ min_height=“100px“ custom_margin=“0px||0px||false|false“ custom_padding=“42px||89px|||“ top_divider_style=“slant2″ top_divider_color=“#eff1f4″ top_divider_height=“75px“ top_divider_height_tablet=““ top_divider_height_phone=“50px“ top_divider_height_last_edited=“on|phone“ bottom_divider_style=“slant2″ bottom_divider_color=“#ffffff“ bottom_divider_height_tablet=““ bottom_divider_height_phone=“51px“ bottom_divider_height_last_edited=“on|phone“ global_colors_info=“{}“ background__hover_enabled=“off|desktop“][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ module_alignment=“center“ custom_margin=“|-1px||-1px|false|false“ custom_margin_tablet=““ custom_margin_phone=““ custom_margin_last_edited=“on|phone“ custom_padding=“34px|0px|5px|0px|false|false“ custom_padding_tablet=“65px||||false|false“ custom_padding_phone=“35px|0px|13px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Prom\u00edt\u00e1n\u00ed literatury<\/h2>\n

Scientific journals are important sources of Adverse Drug Reaction reports and other safety relevant information. V\u00fdrobc\u016fm l\u00e9k\u016f je na\u0159\u00edzeno zajistit d\u016fkladn\u00fd a pravideln\u00fd screening p\u0159\u00edslu\u0161n\u00e9 literatury. <\/p>

V z\u00e1vislosti na pokryt\u00ed va\u0161eho trhu budete muset prov\u00e1d\u011bt monitorov\u00e1n\u00ed v glob\u00e1ln\u00edch datab\u00e1z\u00edch, jako je PubMed nebo Embase, ale tak\u00e9 se mo\u017en\u00e1 budete muset bl\u00ed\u017ee pod\u00edvat na neindexovan\u00e9 \u010dasopisy v m\u00edstn\u00edch jazyc\u00edch na va\u0161ich trz\u00edch. Je zapot\u0159eb\u00ed jak glob\u00e1ln\u00edch, tak m\u00edstn\u00edch odborn\u00fdch znalost\u00ed v oblasti PV, a pr\u00e1v\u011b v tom v\u00e1m m\u016f\u017eeme pomoci. <\/p>“ content_phone=““ content_last_edited=“on|tablet“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“Montserrat||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_text_color=“#312533″ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ max_width_tablet=““ max_width_phone=““ max_width_last_edited=“on|tablet“ custom_margin=“0px||||false|false“ custom_margin_tablet=“0px|0px||0px|false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||||false|false“ custom_padding_tablet=“|0px||0px|false|false“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Spr\u00e1va sign\u00e1l\u016f<\/h2>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ module_alignment=“center“ custom_margin=“0px|0px||0px|false|false“ custom_padding=“3px|0px|3px|0px|true|false“ custom_padding_tablet=““ custom_padding_phone=“65px|0px|65px|0px|true|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“justified“ custom_margin=“10px||10px||false|false“ custom_margin_tablet=““ custom_margin_phone=“10px||0px||false|false“ custom_margin_last_edited=“on|phone“ custom_padding_tablet=“10px||||false|false“ custom_padding_phone=“0px||||false|false“ custom_padding_last_edited=“on|phone“ text_orientation_tablet=““ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ global_colors_info=“{}“]

Once your products are on the market, it\u2019s important to keep an eye on their safety profile and how it evolves over time. Dodr\u017eov\u00e1n\u00ed d\u016fkladn\u00e9ho procesu \u0159\u00edzen\u00ed sign\u00e1l\u016f po celou dobu \u017eivotn\u00edho cyklu p\u0159\u00edpravku je kl\u00ed\u010dovou sou\u010d\u00e1st\u00ed kompletn\u00edho farmakovigilan\u010dn\u00edho syst\u00e9mu a mus\u00ed b\u00fdt definov\u00e1no tak\u00e9 v PSMF (z\u00e1kladn\u00edm dokumentu farmakovigilan\u010dn\u00edho syst\u00e9mu). <\/p>

Jako MAH jste zodpov\u011bdn\u00ed za sledov\u00e1n\u00ed v\u0161ech bezpe\u010dnostn\u011b relevantn\u00edch informac\u00ed a ur\u010den\u00ed, zda se objevila n\u011bjak\u00e1 nov\u00e1 rizika t\u00fdkaj\u00edc\u00ed se va\u0161eho v\u00fdrobku. M\u011bli byste prov\u011b\u0159ovat zpr\u00e1vy o bezpe\u010dnosti jednotliv\u00fdch p\u0159\u00edpad\u016f (ICSR) a souhrnn\u00e9 \u00fadaje ze v\u0161ech \u010dinnost\u00ed PV, v\u010detn\u011b v\u011bdeck\u00e9 literatury a dal\u0161\u00edch zdroj\u016f. <\/p>[\/et_pb_text][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“justified“ custom_margin=“10px||10px||false|false“ custom_padding_tablet=“||10px||false|false“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ text_orientation_tablet=““ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ global_colors_info=“{}“]

Typical process would go from signal detection to validation and assessment of a potential emergent safety issue. Pro \u0159\u00edzen\u00ed sign\u00e1l\u016f v\u0161ak neexistuje \u017e\u00e1dn\u00fd univerz\u00e1ln\u00ed proces, kter\u00fd by vyhovoval v\u0161em. <\/p>

M\u011bli byste zv\u00e1\u017eit relevantn\u00ed zdroje pro v\u00e1\u0161 produkt, \u010detnost rutinn\u00edho posuzov\u00e1n\u00ed sign\u00e1l\u016f, stanoven\u00ed priorit sign\u00e1l\u016f a mnoho dal\u0161\u00edch faktor\u016f.<\/p>

Z praktick\u00e9ho hlediska je vhodn\u00e9 posoudit, zda je pro va\u0161i situaci nejvhodn\u011bj\u0161\u00ed rutinn\u00ed manu\u00e1ln\u00ed proces, nebo pokro\u010dil\u00e1 technick\u00e1 anal\u00fdza dat a statistick\u00e1 anal\u00fdza.<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.4.9″ width=“100%“ max_width=“2560px“ custom_margin=“0px||||false|false“ custom_padding=“10px||2px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“center“ width=“80%“ max_width=“1080px“ module_alignment=“center“ custom_padding=“||20px|||“ text_orientation_tablet=“center“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ global_colors_info=“{}“]

Do you need expert advice on your signal management process and activities? Just reach out. <\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ custom_padding_last_edited=“on|phone“ _builder_version=“4.4.9″ use_background_color_gradient=“on“ background_color_gradient_start=“#ffffff“ background_color_gradient_end=“#ffffff“ custom_margin=“1px||||false|false“ custom_padding=“4px||1px||false|false“ custom_padding_tablet=““ custom_padding_phone=“15px||35px||false|false“ top_divider_color=“#F1F3F5″ top_divider_height=“89px“ top_divider_height_tablet=““ top_divider_height_phone=“20px“ top_divider_height_last_edited=“on|phone“ bottom_divider_color=“#f4f5f7″ bottom_divider_height=“53px“ bottom_divider_flip=“horizontal“ bottom_divider_height_tablet=““ bottom_divider_height_phone=“25px“ bottom_divider_height_last_edited=“on|phone“ global_colors_info=“{}“][et_pb_row _builder_version=“4.4.9″ custom_margin=“0px||||false|false“ custom_padding=“1px||1px||false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_tablet=“

Prom\u00edt\u00e1n\u00ed literatury<\/h2>\n

Scientific journals are important sources of Adverse Drug Reaction reports and other safety relevant information. V\u00fdrobc\u016fm l\u00e9k\u016f je na\u0159\u00edzeno zajistit d\u016fkladn\u00fd a pravideln\u00fd screening p\u0159\u00edslu\u0161n\u00e9 literatury. <\/p>

V z\u00e1vislosti na pokryt\u00ed va\u0161eho trhu budete muset prov\u00e1d\u011bt monitorov\u00e1n\u00ed v glob\u00e1ln\u00edch datab\u00e1z\u00edch, jako je PubMed nebo Embase, ale tak\u00e9 se mo\u017en\u00e1 budete muset bl\u00ed\u017ee pod\u00edvat na neindexovan\u00e9 \u010dasopisy v m\u00edstn\u00edch jazyc\u00edch na va\u0161ich trz\u00edch. Je zapot\u0159eb\u00ed jak glob\u00e1ln\u00edch, tak m\u00edstn\u00edch odborn\u00fdch znalost\u00ed v oblasti PV, a pr\u00e1v\u011b v tom v\u00e1m m\u016f\u017eeme pomoci. <\/p>“ content_phone=““ content_last_edited=“on|tablet“ _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“Montserrat||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_text_color=“#312533″ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ max_width_tablet=““ max_width_phone=““ max_width_last_edited=“on|tablet“ custom_margin=“0px||||false|false“ custom_margin_tablet=“0px|0px||0px|false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||||false|false“ custom_padding_tablet=“|0px||0px|false|false“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Souhrnn\u00e9 zpr\u00e1vy<\/h2>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.4.9″ width=“100%“ max_width=“2560px“ custom_margin=“0px||||false|false“ custom_padding=“10px||2px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ text_orientation=“center“ width=“80%“ max_width=“1080px“ module_alignment=“center“ custom_padding=“||20px|||“ text_orientation_tablet=“center“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ global_colors_info=“{}“]

Similar to your signal management activities, as you monitor the evolution of your product(s) safety profile, you should evaluate any new safety information in a periodic aggregate report. <\/p>\n

In the EU and in many other countries, this is called Period Safety Update Report and it should include an aggregate info on all safety relevant information in a given time period. The frequency largely depends on how new the product is.<\/p>\n

And yes, we can take care of your responsibility to put together and submit these periodic reports.<\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.4.9″ background_color=“#0c9cd1″ use_background_color_gradient=“on“ background_color_gradient_start=“#F4F5F7″ background_color_gradient_end=“#F4F5F7″ custom_margin=“-1px||||false|false“ custom_padding=“0px||21px||false|false“ top_divider_style=“slant2″ top_divider_color=“#ffffff“ top_divider_height=“75px“ top_divider_flip=“horizontal“ global_colors_info=“{}“][et_pb_row _builder_version=“4.4.3″ custom_padding=“92px|||||“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“3.25″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_font_size=“18px“ text_line_height=“2em“ ul_font=“||||||||“ ol_font=“||||||||“ header_font=“||||||||“ header_2_font=“Montserrat|700|||||||“ header_2_font_size=“36px“ header_2_line_height=“1.6em“ header_3_font=“Merriweather|700|||||||“ header_3_text_color=“#ffc47c“ header_3_font_size=“18px“ header_3_line_height=“1.8em“ header_4_font=“||||||||“ header_5_font=“||||||||“ header_6_font=“||||||||“ text_orientation=“center“ custom_margin=“||5px|||“ header_2_font_size_tablet=““ header_2_font_size_phone=“28px“ header_2_font_size_last_edited=“on|phone“ header_3_font_size_tablet=““ header_3_font_size_phone=“14px“ header_3_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Poj\u010fme si popov\u00eddat<\/h2>[\/et_pb_text][et_pb_text _builder_version=“4.4.9″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_line_height=“1.5em“ text_orientation=“center“ global_colors_info=“{}“]

A\u0165 u\u017e jsou va\u0161e pot\u0159eby jak\u00e9koli, t\u011b\u0161\u00edme se, a\u017e se s v\u00e1mi spoj\u00edme.
Nev\u00e1hejte n\u00e1m napsat zpr\u00e1vu a my v\u00e1s budeme ihned kontaktovat.<\/span><\/p>[\/et_pb_text][et_pb_button button_url=“https:\/\/www.tepsivo.com\/book-a-free-15-minute-consultation\/“ button_text=“Zarezervujte si 15minutovou konzultaci ZDARMA“ button_alignment=“center“ module_class=“primary-button“ _builder_version=“4.4.9″ custom_button=“on“ button_text_size=“16px“ button_text_color=“#b5302f“ button_bg_color=“#ffffff“ button_border_width=“2px“ button_border_color=“#ffffff“ button_border_radius=“19px“ button_font=“Montserrat||||||||“ button_use_icon=“off“ custom_margin=“|10px||0px|false|false“ custom_padding=“9px|30px|9px|30px|true|false“ global_colors_info=“{}“][\/et_pb_button][et_pb_button button_url=“https:\/\/www.tepsivo.com\/contact\/“ button_text=“Napi\u0161te zpr\u00e1vu“ button_alignment=“center“ module_class=“secondary-button“ _builder_version=“4.4.9″ custom_button=“on“ button_text_size=“16px“ button_text_color=“#ffffff“ button_bg_color=“#b5302f“ button_border_width=“2px“ button_border_color=“#b5302f“ button_border_radius=“19px“ button_font=“Montserrat||||||||“ button_use_icon=“off“ custom_margin=“|10px||0px|false|false“ custom_padding=“9px|80px|9px|80px|false|false“ custom_padding_tablet=““ custom_padding_phone=“9px|45px|9px|45px|false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.4.3″ background_color=“#F4F5F7″ custom_padding=“5px||0px|||“ border_color_all=“#8F909D“ border_width_top=“1px“ border_style_top=“dashed“ global_colors_info=“{}“][et_pb_row _builder_version=“4.4.3″ custom_padding=“15px||14px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.4.3″ global_colors_info=“{}“][et_pb_text _builder_version=“4.14.7″ text_font=“Montserrat||||||||“ text_orientation=“center“ hover_enabled=“0″ global_colors_info=“{}“ sticky_enabled=“0″]

Tepsivo Oy |\u00a0Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | contact@tepsivo.com\u00a0 <\/a>| +358 402 204 698 | Privacy policy<\/u><\/a><\/p>\n\n