{"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":"2026-08-16T10:56:35","modified_gmt":"2026-08-16T10:56:35","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

Pravidla farmakovigilance v Evrop\u011b jsou slo\u017eit\u00e1. Jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 odborn\u00e9 znalosti a efektivn\u00ed mezin\u00e1rodn\u00ed provoz ze strany ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Na\u0161t\u011bst\u00ed je to na\u0161e specialita. Pom\u016f\u017eeme v\u00e1m s kompletn\u00edm syst\u00e9mem farmakovigilance v EU nebo jen s vybran\u00fdmi slu\u017ebami.<\/p>“ content_phone=“

Evropsk\u00e1 farmakovigilance<\/h2>\n

Pravidla farmakovigilance v Evrop\u011b jsou slo\u017eit\u00e1. Jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 odborn\u00e9 znalosti a efektivn\u00ed mezin\u00e1rodn\u00ed provoz ze strany ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Na\u0161t\u011bst\u00ed je to na\u0161e specialita. Pom\u016f\u017eeme v\u00e1m s kompletn\u00edm syst\u00e9mem farmakovigilance v EU nebo jen s vybran\u00fdmi slu\u017ebami.<\/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 to farmakovigilance?<\/h2>[\/et_pb_text][et_pb_text content_tablet=“

Evropsk\u00e1 farmakovigilance<\/h2>\n

Pravidla farmakovigilance v Evrop\u011b jsou slo\u017eit\u00e1. Jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 odborn\u00e9 znalosti a efektivn\u00ed mezin\u00e1rodn\u00ed provoz ze strany ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Na\u0161t\u011bst\u00ed je to na\u0161e specialita. Pom\u016f\u017eeme v\u00e1m s kompletn\u00edm syst\u00e9mem farmakovigilance v EU nebo jen s vybran\u00fdmi slu\u017ebami.<\/p>“ content_phone=“

Evropsk\u00e1 farmakovigilance<\/h2>\n

Pravidla farmakovigilance v Evrop\u011b jsou slo\u017eit\u00e1. Jejich dodr\u017eov\u00e1n\u00ed vy\u017eaduje hlubok\u00e9 odborn\u00e9 znalosti a efektivn\u00ed mezin\u00e1rodn\u00ed provoz ze strany ka\u017ed\u00e9ho dr\u017eitele rozhodnut\u00ed o registraci (MAH). Na\u0161t\u011bst\u00ed je to na\u0161e specialita. Pom\u016f\u017eeme v\u00e1m s kompletn\u00edm syst\u00e9mem farmakovigilance v EU nebo jen s vybran\u00fdmi slu\u017ebami.<\/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 n\u00e1sledovn\u011b:<\/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=“{}“]

\u201eV\u011bda a \u010dinnosti t\u00fdkaj\u00edc\u00ed se zji\u0161\u0165ov\u00e1n\u00ed, hodnocen\u00ed, pochopen\u00ed a prevence ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f nebo jin\u00fdch probl\u00e9m\u016f souvisej\u00edc\u00edch s l\u00e9\u010divy.\u201c<\/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=“{}“]

Samotn\u00e1 definice v\u00e1m pravd\u011bpodobn\u011b ne\u0159ekne mnoho o tom, jak\u00e9 jsou va\u0161e povinnosti jako dr\u017eitele rozhodnut\u00ed o registraci (MAH). Tato str\u00e1nka v\u00e1m pom\u016f\u017ee pochopit po\u017eadavky na farmakovigilanci, kter\u00e9 mus\u00edte jako MAH splnit, abyste byli v souladu s p\u0159edpisy a vyhnuli se probl\u00e9m\u016fm p\u0159i kontrol\u00e1ch. <\/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\n

Farmakovigilan\u010dn\u00ed aplikace v cloudu<\/p>\n

Validovan\u00e1<\/p>\n

Dostupn\u00e1 z po\u010d\u00edta\u010de, telefonu i tabletu<\/p>\n

Vyu\u017e\u00edv\u00e1 automatiza\u010dn\u00ed n\u00e1stroje<\/p>\n

Kapacita pro neomezen\u00e9 mno\u017estv\u00ed dat<\/p>\n

Vede auditn\u00ed stopu<\/p>\n

V souladu s GDPR<\/p>\n

Velmi intuitivn\u00ed a snadno ovladateln\u00e1<\/p>\n

A dal\u0161\u00ed\u2026<\/p>“ content_phone=“

Funkce<\/h4>\n\n

Farmakovigilan\u010dn\u00ed aplikace v cloudu<\/p>\n

\n

Validovan\u00e1<\/p>\n

\n

Dostupn\u00e1 z po\u010d\u00edta\u010de, telefonu i tabletu<\/p>\n

\n

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

\n

Kapacita pro neomezen\u00e9 mno\u017estv\u00ed dat farmakovigilance<\/p>\n

\n

Sledov\u00e1n\u00ed z\u00e1znam\u016f o auditech<\/p>\n

\n

V souladu s GDPR<\/p>\n

\n

Velmi intuitivn\u00ed a snadn\u00e9 ovl\u00e1d\u00e1n\u00ed<\/p>\n

\n

A mnohem v\u00edce\u2026<\/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=“{}“]

Tato str\u00e1nka slou\u017e\u00ed jako stru\u010dn\u00fd p\u0159ehled<\/strong> pro ty, kte\u0159\u00ed se neorientuj\u00ed v po\u017eadavc\u00edch na farmakovigilanci v EU a ve sv\u011bt\u011b. Pokud se chcete do legislativy pono\u0159it hloub\u011bji, \u0159i\u010fte se odkazy v pozn\u00e1mk\u00e1ch pod \u010darou. <\/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=“

V\u00fdhody<\/h4>\n\n

V\u00fdrazn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu pot\u0159ebn\u00fdch FTE (ekvivalent\u016f pln\u00e9ho pracovn\u00edho \u00favazku) na projekt<\/p>\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita a \u00faspora \u010dasu<\/p>\n

Eliminace nadbyte\u010dn\u00fdch tabulek a krok\u016f QC (kontroly kvality)<\/p>\n

P\u0159\u00edstup ke v\u0161em aktivit\u00e1m farmakovigilance v re\u00e1ln\u00e9m \u010dase<\/p>\n

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

Vyu\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu slu\u017eeb farmakovigilance<\/p>\n

Vy\u0161\u0161\u00ed kvalita vstupn\u00edch dat farmakovigilance<\/p>\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 dashboardy s daty a statistikami projektu<\/p>\n

A mnohem v\u00edce\u2026<\/p>“ content_phone=“

V\u00fdhody<\/h4>\n\n

V\u00fdrazn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu pot\u0159ebn\u00fdch FTE (ekvivalent\u016f pln\u00e9ho pracovn\u00edho \u00favazku) na projekt<\/p>\n

\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita a \u00faspora \u010dasu<\/p>\n

\n

Eliminace nadbyte\u010dn\u00fdch tabulek a krok\u016f QC (kontroly kvality)<\/p>\n

\n

P\u0159\u00edstup ke v\u0161em aktivit\u00e1m farmakovigilance v re\u00e1ln\u00e9m \u010dase<\/p>\n

\n

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

\n

Vyu\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu slu\u017eeb farmakovigilance<\/p>\n

\n

Vy\u0161\u0161\u00ed kvalita vstupn\u00edch dat farmakovigilance<\/p>\n

\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 dashboardy s daty a statistikami projektu<\/p>\n

A mnohem v\u00edc\u2026<\/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=“{}“]

Pokud jste odborn\u00edkem na farmakovigilanci nebo se v oboru orientujete<\/strong>, mo\u017en\u00e1 v\u00e1s bude zaj\u00edmat, jak inovujeme a modernizujeme sv\u011bt farmakovigilance: pod\u00edvejte se na str\u00e1nky Automatizace<\/a> nebo O n\u00e1s<\/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 slu\u017eby v\u00e1m m\u016f\u017eeme nab\u00eddnout:<\/h3>\n

<\/p>“ content_phone=“

Jak\u00e9 slu\u017eby v\u00e1m 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 farmakovigilan\u010dn\u00ed terminologi\u00ed:<\/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=“{}“]

Syst\u00e9m farmakovigilance 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 (RMP)<\/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=“{}“]

Management 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=“

Glob\u00e1ln\u00ed a lok\u00e1ln\u00ed screening literatury<\/h4>“ content_phone=“

Glob\u00e1ln\u00ed a lok\u00e1ln\u00ed screening 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=“{}“]

Odpov\u011bdn\u00e1 osoba pro farmakovigilanci v EU (EU QPPV)<\/h4>[\/et_pb_text][et_pb_text content_tablet=“

P\u0159\u00edprava dokumentace PSMF<\/h4>“ content_phone=“

P\u0159\u00edprava dokumentace PSMF<\/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=“{}“]

Spr\u00e1va ICSR<\/h4>[\/et_pb_text][et_pb_text content_tablet=“

Management sign\u00e1l\u016f<\/h4>“ content_phone=“

Management 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=“{}“]

Lok\u00e1ln\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=“

Nach\u00e1z\u00edte se v jin\u00e9 situaci a nejste si jist\u00ed, jak\u00e9 jsou va\u0161e regulatorn\u00ed a farmakovigilan\u010dn\u00ed povinnosti?<\/p>\n

\u017d\u00e1dn\u00fd probl\u00e9m! Zarezervujte si bezplatnou 15minutovou konzultaci a spole\u010dn\u011b na to p\u0159ijdeme.<\/a><\/p>“ content_phone=“

Nach\u00e1z\u00edte se v jin\u00e9 situaci a nejste si jist\u00ed, jak\u00e9 jsou va\u0161e regulatorn\u00ed a farmakovigilan\u010dn\u00ed povinnosti?<\/p>\n

\u017d\u00e1dn\u00fd probl\u00e9m!Zarezervujte si bezplatnou 15minutovou konzultaci a spole\u010dn\u011b na to p\u0159ijdeme.<\/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\u00e1sleduj\u00edc\u00ed text slou\u017e\u00ed jako bezplatn\u00fd informa\u010dn\u00ed a vzd\u011bl\u00e1vac\u00ed p\u0159ehled povinnost\u00ed dr\u017eitel\u016f rozhodnut\u00ed o registraci (MAH) v oblasti farmakovigilance. V \u017e\u00e1dn\u00e9m p\u0159\u00edpad\u011b jej nelze pova\u017eovat za odborn\u00e9 poradenstv\u00ed ani za \u00fapln\u00fd v\u00fd\u010det p\u0159\u00edslu\u0161n\u00e9 legislativy 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=“{}“]

Farmakovigilan\u010dn\u00ed syst\u00e9mov\u00fd hlavn\u00ed soubor (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=“{}“]

Jako n\u00e1v\u0161t\u011bvn\u00edk webu farmakovigilan\u010dn\u00ed spole\u010dnosti jste o n\u011bm pravd\u011bpodobn\u011b u\u017e sly\u0161eli. PSMF je kl\u00ed\u010dov\u00fd dokument, kter\u00fd definuje v\u00e1\u0161 syst\u00e9m farmakovigilance v EU. Popisuje v\u0161echny procesy a struktury, kter\u00e9 jako dr\u017eitel rozhodnut\u00ed o registraci (MAH) vyu\u017e\u00edv\u00e1te k zaji\u0161t\u011bn\u00ed souladu s GVP a legislativou EU. Dokument mus\u00edte pravideln\u011b udr\u017eovat a aktualizovat, abyste mohli provozovat farmakovigilan\u010dn\u00ed \u010dinnost, a na vy\u017e\u00e1d\u00e1n\u00ed jej p\u0159edlo\u017eit \u00fa\u0159ad\u016fm ke kontrole. \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=“{}“]

P\u0159i pod\u00e1v\u00e1n\u00ed \u017e\u00e1dosti o registraci l\u00e9\u010div\u00e9ho p\u0159\u00edpravku (MA) mus\u00edte dodat souhrn PSMF. Nejlep\u0161\u00ed je p\u0159ipravit si tento dokument je\u0161t\u011b p\u0159ed pod\u00e1n\u00edm \u017e\u00e1dosti. V souhrnu uvedete svou odpov\u011bdnou osobu pro farmakovigilanci v EU (EU QPPV). PSMF by se m\u011bl obvykle nach\u00e1zet v m\u00edst\u011b, kde p\u016fsob\u00ed EU QPPV (p\u0159\u00edpadn\u011b v m\u00edst\u011b, kde prob\u00edhaj\u00ed farmakovigilan\u010dn\u00ed \u010dinnosti).<\/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=“{}“]

Pot\u0159ebujete pomoci s p\u0159\u00edpravou PSMF? Jsme tu pro v\u00e1s. <\/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=“{}“]

Odborn\u011b zp\u016fsobil\u00e1 osoba pro farmakovigilanci v EU (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 prod\u00e1vat l\u00e9\u010div\u00fd p\u0159\u00edpravek v EU nebo u\u017e ho prod\u00e1v\u00e1te, pot\u0159ebujete zku\u0161en\u00e9ho experta na farmakovigilanci. Mus\u00ed perfektn\u011b zn\u00e1t pokyny EMA a sm\u011brnice EU pro farmakovigilanci, aby mohl p\u0159evz\u00edt roli odborn\u011b zp\u016fsobil\u00e9 osoby (QPPV). <\/p>

Tento \u010dlov\u011bk je pro \u00fa\u0159ady va\u0161\u00edm hlavn\u00edm kontaktem. M\u00e1 na starosti dohled nad syst\u00e9mem farmakovigilance (podle PSMF) a samoz\u0159ejm\u011b poskytuje odborn\u00e9 vstupy k bezpe\u010dnosti va\u0161ich produkt\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=“{}“]

EU QPPV mus\u00edte jmenovat u\u017e p\u0159i pod\u00e1n\u00ed \u017e\u00e1dosti o registraci (MA). Tato informace je sou\u010d\u00e1st\u00ed souhrnu PSMF. Proto si zajist\u011bte spr\u00e1vn\u00e9ho \u010dlov\u011bka je\u0161t\u011b p\u0159edt\u00edm, ne\u017e \u017e\u00e1dost ode\u0161lete.<\/p>

QPPV mus\u00ed m\u00edt odpov\u00eddaj\u00edc\u00ed kvalifikaci, hlubok\u00e9 znalosti GVP a p\u0159edpis\u016f pro farmakovigilanci. 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=“{}“]

Pokud nem\u00e1te roli EU QPPV pokrytou intern\u011b, m\u016f\u017eete tuto pozici snadno outsourcovat na Tepsivo a vyu\u017e\u00edt n\u011bkter\u00e9ho z na\u0161ich QPPV.<\/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 (RMP)<\/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=“

Tepsivo jsme zalo\u017eili s jasnou viz\u00ed: prom\u011bnit farmakovigilanci v modern\u00ed byznys. To dok\u00e1\u017eeme jen s t\u011bmi spr\u00e1vn\u00fdmi n\u00e1stroji a postupy. Automatizace v tom bude hr\u00e1t kl\u00ed\u010dovou roli, ale jen tehdy, pokud ji vyu\u017eijeme spr\u00e1vn\u011b.<\/p>\n

Zat\u00edm jsme pozorn\u011b sledovali, jak se automatizace vyv\u00edj\u00ed u ostatn\u00edch poskytovatel\u016f, a up\u0159\u00edmn\u011b \u2013 nejsme nad\u0161en\u00ed. Je sice trendy mluvit o mo\u017enostech AI a sni\u017eov\u00e1n\u00ed manu\u00e1ln\u00ed pr\u00e1ce, ale kde jsou v\u00fdsledky?<\/p>

Jednoduch\u00e1 odpov\u011b\u010f zn\u00ed: technologie na to zat\u00edm nesta\u010d\u00ed. Mo\u017en\u00e1 si budeme muset je\u0161t\u011b chv\u00edli po\u010dkat, ne\u017e budeme moci zpracov\u00e1vat tis\u00edce ICSR s minimem rutinn\u00ed pr\u00e1ce. Ale pro\u010d nevyu\u017e\u00edt to, co modern\u00ed technologie zvl\u00e1daj\u00ed u\u017e dnes? P\u0159esn\u011b to d\u011bl\u00e1me v na\u0161\u00ed aplikaci Tepsivo PV.<\/p>\n

<\/p>“ content_phone=“

Tepsivo jsme zalo\u017eili s jasnou viz\u00ed: prom\u011bnit farmakovigilanci v modern\u00ed byznys. To dok\u00e1\u017eeme jen s t\u011bmi spr\u00e1vn\u00fdmi n\u00e1stroji a postupy. Automatizace v tom bude hr\u00e1t kl\u00ed\u010dovou roli, ale jen tehdy, pokud ji vyu\u017eijeme spr\u00e1vn\u011b.<\/p>\n

Zat\u00edm jsme pozorn\u011b sledovali, jak se automatizace vyv\u00edj\u00ed u ostatn\u00edch poskytovatel\u016f, a up\u0159\u00edmn\u011b \u2013 nejsme nad\u0161en\u00ed. Je sice trendy mluvit o mo\u017enostech AI a sni\u017eov\u00e1n\u00ed manu\u00e1ln\u00ed pr\u00e1ce, ale kde jsou v\u00fdsledky?<\/p>

Jednoduch\u00e1 odpov\u011b\u010f zn\u00ed: technologie na to zat\u00edm nesta\u010d\u00ed. Mo\u017en\u00e1 si budeme muset je\u0161t\u011b chv\u00edli po\u010dkat, ne\u017e budeme moci zpracov\u00e1vat tis\u00edce ICSR s minimem rutinn\u00ed pr\u00e1ce. Ale pro\u010d nevyu\u017e\u00edt to, co modern\u00ed technologie zvl\u00e1daj\u00ed u\u017e dnes? P\u0159esn\u011b to d\u011bl\u00e1me v na\u0161\u00ed aplikaci Tepsivo PV.<\/p>\n

<\/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_margin=“||-41px||false|false“ custom_padding=“12px|||||“ custom_padding_tablet=“0px||||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=“center“ text_orientation_phone=“justified“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]

Spole\u010dn\u011b se souhrnem PSMF mus\u00edte k \u017e\u00e1dosti o registraci p\u0159ilo\u017eit i pl\u00e1n \u0159\u00edzen\u00ed rizik (RMP). Jak asi tu\u0161\u00edte, tento dokument popisuje, jak budete rizika \u0159\u00eddit. B\u011bhem \u017eivotn\u00edho cyklu produktu mus\u00edte RMP aktualizovat \u2013 bu\u010f na \u017e\u00e1dost EMA \u010di n\u00e1rodn\u00edch \u00fa\u0159ad\u016f, nebo kdy\u017e se objev\u00ed nov\u00e9 informace, kter\u00e9 mohou ovlivnit bezpe\u010dnostn\u00ed profil produktu.<\/p>\n

RMP je komplexn\u00ed dokument. Obsahuje bezpe\u010dnostn\u00ed specifikaci, pl\u00e1n farmakovigilance, pl\u00e1ny studi\u00ed \u00fa\u010dinnosti po registraci a opat\u0159en\u00ed k minimalizaci rizik. Jeho sestaven\u00ed vy\u017eaduje odborn\u00e9 znalosti a \u010das. <\/p>\n

Pot\u0159ebujete pomoci se sestaven\u00edm pl\u00e1nu \u0159\u00edzen\u00ed rizik? R\u00e1di na tom budeme pracovat s v\u00e1mi.<\/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=“

Lok\u00e1ln\u00ed kontaktn\u00ed osoba pro farmakovigilanci<\/h2>\n

S\u00ed\u0165 lok\u00e1ln\u00edch kontaktn\u00edch osob pro farmakovigilanci (LCPPV), lok\u00e1ln\u00edch QPPV nebo lok\u00e1ln\u00edch pracovn\u00edk\u016f pro farmakovigilanci (LSO) od Tepsiva pokr\u00fdv\u00e1 v\u0161echny sv\u011btov\u00e9 regiony a v\u00edce ne\u017e 150 zem\u00ed.<\/p>

Pokud pot\u0159ebujete lok\u00e1ln\u00ed odborn\u00edky na farmakovigilanci, 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=“{}“]

Spr\u00e1va ICSR<\/h2>\n

Sb\u011br a hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f (nebo jejich podez\u0159en\u00ed) u registrovan\u00fdch l\u00e9k\u016f je kl\u00ed\u010dovou povinnost\u00ed dr\u017eitel\u016f rozhodnut\u00ed o registraci (MAH). Pro \u00fa\u010dely tohoto p\u0159ehledu v\u0161e shrnujeme pod spr\u00e1vu hl\u00e1\u0161en\u00ed o bezpe\u010dnosti jednotliv\u00fdch p\u0159\u00edpad\u016f (ICSR), i kdy\u017e mezi ICSR, ne\u017e\u00e1douc\u00edmi p\u0159\u00edhodami a ne\u017e\u00e1douc\u00edmi \u00fa\u010dinky 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=“{}“]

V podstat\u011b mus\u00edte m\u00edt syst\u00e9m, kter\u00fd zachyt\u00ed v\u0161echna podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinky, ulo\u017e\u00ed je, validuje jako ICSR a ode\u0161le EMA \u010di dal\u0161\u00edm \u00fa\u0159ad\u016fm. Zdroje mohou b\u00fdt r\u016fzn\u00e9, hlavn\u011b rozli\u0161ujeme mezi nevy\u017e\u00e1dan\u00fdmi a vy\u017e\u00e1dan\u00fdmi hl\u00e1\u0161en\u00edmi. <\/p>\n

Typick\u00fdmi zdroji nevy\u017e\u00e1dan\u00fdch hl\u00e1\u0161en\u00ed jsou dotazy pacient\u016f (web, telefon), z\u00e1stupci spole\u010dnosti, zdravotn\u00edci, soci\u00e1ln\u00ed s\u00edt\u011b (a internet obecn\u011b), odborn\u00e1 literatura (viz n\u00ed\u017ee) a mnoho dal\u0161\u00edch n\u00e1hodn\u00fdch zdroj\u016f. <\/p>\n

Vy\u017e\u00e1dan\u00e1 hl\u00e1\u0161en\u00ed obvykle poch\u00e1zej\u00ed z organizovan\u00fdch program\u016f sb\u011bru dat, jako jsou klinick\u00e9 studie, neinterven\u010dn\u00ed studie, programy pro konkr\u00e9tn\u00ed pacienty, soucitn\u00e9 pou\u017eit\u00ed, pr\u016fzkumy a podobn\u011b.<\/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 v\u0161echny p\u0159edpisy?<\/h4>\n

Po\u017eadavky na lok\u00e1ln\u00ed farmakovigilanci jsou slo\u017eit\u00e9 a nav\u00edc se neust\u00e1le m\u011bn\u00ed. Kl\u00ed\u010dem je d\u016fkladn\u00fd p\u0159ehled o glob\u00e1ln\u00ed legislativ\u011b. Sledujeme v\u0161echny n\u00e1rodn\u00ed \u00fa\u0159ady a o ka\u017ed\u00e9 zm\u011bn\u011b v\u00edme. D\u00edky tomu maj\u00ed na\u0161i klienti v\u017edy aktu\u00e1ln\u00ed informace a na legislativn\u00ed novinky dok\u00e1\u017eou v\u010das zareagovat.<\/p>\n

Chcete v\u011bd\u011bt v\u00edc? Zarezervujte si bezplatnou 15minutovou konzultaci.<\/a><\/p>“ content_phone=“

M\u00e1te v\u0161e v souladu s p\u0159edpisy?<\/h4>\n

Po\u017eadavky na lok\u00e1ln\u00ed farmakovigilanci jsou slo\u017eit\u00e9 a nav\u00edc se neust\u00e1le m\u011bn\u00ed. Kl\u00ed\u010dem je d\u016fkladn\u00fd p\u0159ehled o glob\u00e1ln\u00ed legislativ\u011b. Sledujeme v\u0161echny n\u00e1rodn\u00ed \u00fa\u0159ady a o ka\u017ed\u00e9 zm\u011bn\u011b v\u00edme. D\u00edky tomu maj\u00ed na\u0161i klienti v\u017edy aktu\u00e1ln\u00ed informace a na legislativn\u00ed novinky dok\u00e1\u017eou v\u010das zareagovat.<\/p>\n

Chcete v\u011bd\u011bt v\u00edc? Zarezervujte 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 stane, kdy\u017e p\u0159ijde podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek u va\u0161eho produktu? Mus\u00edte ho validovat jako ICSR a zjistit, zda existuje p\u0159\u00ed\u010dinn\u00e1 souvislost s produktem. Je to trochu slo\u017eit\u011bj\u0161\u00ed, ale zjednodu\u0161en\u011b \u0159e\u010deno mus\u00ed hl\u00e1\u0161en\u00ed spl\u0148ovat 4 minim\u00e1ln\u00ed krit\u00e9ria: identifikovateln\u00fd oznamovatel, identifikovateln\u00fd pacient, podez\u0159el\u00e1 l\u00e1tka\/produkt a podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek.<\/p>\n

Jakmile je ICSR validov\u00e1no, je t\u0159eba jej nahl\u00e1sit. <\/p>\n

Mus\u00edte tak\u00e9 v\u00e9st z\u00e1znamy o ICSR a dal\u0161\u00edch hl\u00e1\u0161en\u00edch. Syst\u00e9my farmakovigilance obvykle vyu\u017e\u00edvaj\u00ed \u201ebezpe\u010dnostn\u00ed datab\u00e1zi\u201c pro spr\u00e1vu cel\u00e9ho procesu \u2013 od p\u0159ijet\u00ed hl\u00e1\u0161en\u00ed a\u017e po jeho odesl\u00e1n\u00ed \u00fa\u0159ad\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=“{}“]

Spr\u00e1va ICSR se snadno stane nejn\u00e1ro\u010dn\u011bj\u0161\u00ed \u010d\u00e1st\u00ed va\u0161\u00ed farmakovigilance. Nejl\u00e9pe ud\u011bl\u00e1te, kdy\u017e vyu\u017eijete syst\u00e9m, kter\u00fd cel\u00fd proces zjednodu\u0161\u00ed a zbav\u00ed v\u00e1s zbyte\u010dn\u00e9 administrativy. Ano, um\u00edme s t\u00edm pomoci\u2026 Ozv\u011bte se n\u00e1m.<\/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=“

Screening literatury<\/h2>\n

Odborn\u00e9 \u010dasopisy jsou d\u016fle\u017eit\u00fdm zdrojem hl\u00e1\u0161en\u00ed o ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch a dal\u0161\u00edch bezpe\u010dnostn\u00edch informac\u00ed. V\u00fdrobci l\u00e9k\u016f maj\u00ed povinnost zajistit jejich d\u016fkladn\u00e9 a pravideln\u00e9 prov\u011b\u0159ov\u00e1n\u00ed. <\/p>

Podle toho, na jak\u00fdch trz\u00edch p\u016fsob\u00edte, budete muset monitorovat glob\u00e1ln\u00ed datab\u00e1ze jako PubMed nebo Embase, ale tak\u00e9 lok\u00e1ln\u00ed \u010dasopisy, kter\u00e9 v nich nejsou indexovan\u00e9. Vy\u017eaduje to glob\u00e1ln\u00ed i lok\u00e1ln\u00ed odbornost \u2013 a p\u0159esn\u011b s t\u00edm v\u00e1m pom\u016f\u017eeme.<\/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=“{}“]

Monitoring literatury<\/h2>\n

Jakmile z\u00edsk\u00e1te registraci l\u00e9\u010div\u00e9ho p\u0159\u00edpravku (MA), mus\u00edte pravideln\u011b sledovat odbornou literaturu a hledat informace o bezpe\u010dnosti. Je to d\u016fle\u017eit\u00fd zdroj \u00fadaj\u016f o mo\u017en\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch a kl\u00ed\u010dov\u00e1 sou\u010d\u00e1st farmakovigilance. Proces d\u011bl\u00edme na dv\u011b \u010d\u00e1sti: 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=“{}“]

Glob\u00e1ln\u00ed monitoring literatury jako dr\u017eitel rozhodnut\u00ed o registraci (MAH) prov\u00e1d\u011bjte systematicky v datab\u00e1z\u00edch jako Medline nebo Embase; jednou t\u00fddn\u011b sta\u010d\u00ed. Pokud zjist\u00edte p\u0159\u00ed\u010dinnou souvislost mezi l\u00e9kem a podez\u0159en\u00edm na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek, \u010dl\u00e1nek vyhodno\u0165te a zpracujte jako individu\u00e1ln\u00ed hl\u00e1\u0161en\u00ed o bezpe\u010dnosti (ICSR).<\/p>\n

To, \u010demu \u0159\u00edk\u00e1me lok\u00e1ln\u00ed screening literatury, je o n\u011bco slo\u017eit\u011bj\u0161\u00ed. V ka\u017ed\u00e9 zemi, kde je v\u00e1\u0161 p\u0159\u00edpravek registrovan\u00fd, mus\u00edte sledovat lok\u00e1ln\u00ed \u010dasopisy, kter\u00e9 nejsou v \u201eglob\u00e1ln\u00edch\u201c datab\u00e1z\u00edch. K tomu pot\u0159ebujete lok\u00e1ln\u00edho experta, kter\u00fd ovl\u00e1d\u00e1 m\u00edstn\u00ed jazyk a zn\u00e1 tamn\u00ed odborn\u00e9 publikace.<\/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=“{}“]

Monitoring literatury zabere hodn\u011b \u010dasu, proto je nejlep\u0161\u00ed vyu\u017e\u00edt digit\u00e1ln\u00ed \u0159e\u0161en\u00ed. Pokud p\u016fsob\u00edte na glob\u00e1ln\u00edch trz\u00edch a pot\u0159ebujete lok\u00e1ln\u00ed podporu, s\u00ed\u0165 expert\u016f Tepsivo ve v\u00edce ne\u017e 150 zem\u00edch pro v\u00e1s m\u016f\u017ee b\u00fdt t\u00edm prav\u00fdm \u0159e\u0161en\u00edm. Ozv\u011bte se n\u00e1m a zjist\u011bte, jak se postar\u00e1me o va\u0161e povinnosti v oblasti literatury.<\/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=“{}“]

Lok\u00e1ln\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 farmakovigilan\u010dn\u00ed aplikace eliminuje zbyte\u010dnou administrativu pomoc\u00ed automatizace. Zaji\u0161\u0165uje vysokou kvalitu vstupn\u00edch dat, jako jsou hl\u00e1\u0161en\u00ed o ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch, d\u00edky p\u0159eddefinovan\u00fdm pol\u00edm, kter\u00e1 propoj\u00edte se svou datab\u00e1z\u00ed. K dat\u016fm m\u00e1te p\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase a nav\u00edc m\u016f\u017eete sledovat p\u0159ehledn\u00e9 dashboardy.<\/p>\n

Ch\u00e1peme, \u017ee ka\u017ed\u00fd klient m\u00e1 specifick\u00e9 pot\u0159eby. Pokud na\u0161e aplikace vy\u017eaduje \u00fapravy, je to v po\u0159\u00e1dku. Je konfigurovateln\u00e1 a funkce v\u00e1m p\u0159izp\u016fsob\u00edme na m\u00edru. \u017d\u00e1dn\u00ed dva na\u0161i klienti toti\u017e nemaj\u00ed aplikaci nastavenou \u00fapln\u011b stejn\u011b.<\/p>“ content_phone=“

Na\u0161e farmakovigilan\u010dn\u00ed aplikace eliminuje zbyte\u010dnou administrativu pomoc\u00ed automatizace. Zaji\u0161\u0165uje vysokou kvalitu vstupn\u00edch dat, jako jsou hl\u00e1\u0161en\u00ed o ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch, d\u00edky p\u0159eddefinovan\u00fdm pol\u00edm, kter\u00e1 propoj\u00edte se svou datab\u00e1z\u00ed. K dat\u016fm m\u00e1te p\u0159\u00edstup v re\u00e1ln\u00e9m \u010dase a nav\u00edc m\u016f\u017eete sledovat p\u0159ehledn\u00e9 dashboardy.<\/p>\n

Ch\u00e1peme, \u017ee ka\u017ed\u00fd klient m\u00e1 specifick\u00e9 pot\u0159eby. Pokud na\u0161e aplikace vy\u017eaduje \u00fapravy, je to v po\u0159\u00e1dku. Je konfigurovateln\u00e1 a funkce v\u00e1m p\u0159izp\u016fsob\u00edme na m\u00edru. \u017d\u00e1dn\u00ed dva na\u0161i klienti toti\u017e nemaj\u00ed aplikaci nastavenou \u00fapln\u011b stejn\u011b.<\/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=“{}“]

Lok\u00e1ln\u00ed screening literatury nen\u00ed va\u0161\u00ed jedinou povinnost\u00ed. Mnoho zem\u00ed EU i sv\u011bta vy\u017eaduje jmenov\u00e1n\u00ed lok\u00e1ln\u00ed kontaktn\u00ed osoby pro farmakovigilanci (LCPPV). N\u011bkdy se tato role naz\u00fdv\u00e1 jinak \u2013 lok\u00e1ln\u00ed QPPV, lok\u00e1ln\u00ed bezpe\u010dnostn\u00ed pracovn\u00edk nebo jinak \u2013 ale v podstat\u011b jde o tot\u00e9\u017e.\n<\/p>\n

Lok\u00e1ln\u00ed kontaktn\u00ed osoba pro farmakovigilanci m\u00e1 podobnou roli jako EU QPPV, ale nese odpov\u011bdnost na \u00farovni dan\u00e9 zem\u011b. Je to hlavn\u00ed spojka mezi v\u00e1mi a m\u00edstn\u00edm \u00fa\u0159adem pro kontrolu l\u00e9\u010div. M\u011bla by zn\u00e1t m\u00edstn\u00ed jazyk, v zemi (ne v\u017edy nutn\u011b) s\u00eddlit a perfektn\u011b se vyznat v tamn\u00edch p\u0159edpisech. \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\n

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

Validovan\u00e1<\/p>\n

Dostupn\u00e1 z po\u010d\u00edta\u010de, telefonu i tabletu<\/p>\n

Vyu\u017e\u00edv\u00e1 automatiza\u010dn\u00ed n\u00e1stroje<\/p>\n

Pojme neomezen\u00e9 mno\u017estv\u00ed farmakovigilan\u010dn\u00edch dat<\/p>\n

Sleduje auditn\u00ed stopu<\/p>\n

V souladu s GDPR<\/p>\n

Velmi intuitivn\u00ed a snadno ovladateln\u00e1<\/p>\n

A mnohem v\u00edce\u2026<\/p>“ content_phone=“

Funkce<\/h4>\n\n

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

\n

Validovan\u00e1<\/p>\n

\n

Dostupn\u00e1 z po\u010d\u00edta\u010de, telefonu i tabletu<\/p>\n

\n

Vyu\u017e\u00edv\u00e1 automatiza\u010dn\u00ed n\u00e1stroje<\/p>\n

\n

Pojme neomezen\u00e9 mno\u017estv\u00ed farmakovigilan\u010dn\u00edch dat<\/p>\n

\n

Sleduje auditn\u00ed stopu<\/p>\n

\n

V souladu s GDPR<\/p>\n

\n

Velmi intuitivn\u00ed a snadno ovladateln\u00e1<\/p>\n

\n

A mnohem v\u00edce\u2026<\/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=“{}“]

Nebojte se, nemus\u00edte hned nab\u00edrat zam\u011bstnance po cel\u00e9m sv\u011bt\u011b.<\/strong> Jm\u00e9nem va\u0161\u00ed spole\u010dnosti zajist\u00edme LCPPV ve v\u00edce ne\u017e 150 zem\u00edch. <\/p>

A co v\u00edc? Kompletn\u00ed glob\u00e1ln\u00ed operace zvl\u00e1dneme pln\u011b automatizovan\u011b p\u0159es na\u0161i platformu pro poskytov\u00e1n\u00ed slu\u017eeb, kde m\u016f\u017eeme dohl\u00ed\u017eet i na va\u0161e intern\u00ed zdroje v pobo\u010dk\u00e1ch. Nedivte se, pokud tuto nab\u00eddku nebudete moci srovnat s jin\u00fdmi \u2013 jsme jedin\u00ed, kdo to d\u011bl\u00e1 takto. <\/p>

Kontaktujte n\u00e1s a my v\u00e1m v\u0161e zajist\u00edme.<\/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=“

V\u00fdhody<\/h4>\n\n

V\u00fdrazn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu pot\u0159ebn\u00fdch FTE<\/p>\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita a \u00faspora \u010dasu<\/p>\n

Eliminuje nadbyte\u010dn\u00e9 sledovac\u00ed n\u00e1stroje a kroky kontroly kvality<\/p>\n

P\u0159\u00edstup ke v\u0161em farmakovigilan\u010dn\u00edm aktivit\u00e1m v re\u00e1ln\u00e9m \u010dase<\/p>\n

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

Vyu\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu slu\u017eeb farmakovigilance<\/p>\n

Vy\u0161\u0161\u00ed kvalita vstupn\u00edch farmakovigilan\u010dn\u00edch dat<\/p>\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 dashboardy s daty a statistikami projekt\u016f<\/p>\n

A mnohem v\u00edce\u2026<\/p>“ content_phone=“

V\u00fdhody<\/h4>\n\n

V\u00fdrazn\u00e9 sn\u00ed\u017een\u00ed po\u010dtu pot\u0159ebn\u00fdch FTE na projekt<\/p>\n

\n

Vysok\u00e1 n\u00e1kladov\u00e1 efektivita a \u00faspora \u010dasu<\/p>\n

\n

Eliminace nadbyte\u010dn\u00fdch tabulek a krok\u016f kontroly kvality (QC)<\/p>\n

\n

P\u0159\u00edstup ke v\u0161em farmakovigilan\u010dn\u00edm aktivit\u00e1m v re\u00e1ln\u00e9m \u010dase<\/p>\n

\n

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

\n

Vyu\u017eiteln\u00e9 pro \u0161irokou \u0161k\u00e1lu slu\u017eeb farmakovigilance<\/p>\n

\n

Vy\u0161\u0161\u00ed kvalita vstupn\u00edch farmakovigilan\u010dn\u00edch dat<\/p>\n

\n

P\u0159ehledn\u00e9 a stru\u010dn\u00e9 dashboardy s daty a statistikami projekt\u016f<\/p>\n

A mnohem v\u00edce\u2026<\/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=“{}“]

V n\u011bkter\u00fdch zem\u00edch je nav\u00edc role LCPPV z\u00e1konn\u00fdm po\u017eadavkem.<\/strong> V jin\u00fdch zem\u00edch je prost\u011b dobrou prax\u00ed m\u00edt na dan\u00e9m trhu n\u011bkoho, kdo za farmakovigilanci odpov\u00edd\u00e1.<\/p>

Po\u017eadavky na tuto roli a jej\u00ed odpov\u011bdnosti se nav\u00edc v ka\u017ed\u00e9 zemi li\u0161\u00ed. Pokud se v\u00e1m z toho nechce to\u010dit hlava p\u0159i zji\u0161\u0165ov\u00e1n\u00ed, co p\u0159esn\u011b a kde mus\u00edte ud\u011blat, vyu\u017eijte p\u0159ehledn\u00e9 reporty o regulatorn\u00edch po\u017eadavc\u00edch, kter\u00e9 \u010derpaj\u00ed data od v\u0161ech p\u0159\u00edslu\u0161n\u00fdch \u00fa\u0159ad\u016f.<\/p>

Pod\u00edvejte se na na\u0161i str\u00e1nku o automatizaci<\/a> nebo n\u00e1s kontaktujte<\/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=“

Monitoring literatury<\/h2>\n

Odborn\u00e9 \u010dasopisy jsou d\u016fle\u017eit\u00fdm zdrojem hl\u00e1\u0161en\u00ed o ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch a dal\u0161\u00edch informac\u00ed o bezpe\u010dnosti. V\u00fdrobci l\u00e9\u010div maj\u00ed povinnost zajistit d\u016fkladn\u00fd a pravideln\u00fd monitoring relevantn\u00ed literatury. <\/p>

Podle rozsahu va\u0161eho trhu mus\u00edte monitorovat glob\u00e1ln\u00ed datab\u00e1ze jako PubMed nebo Embase, ale mo\u017en\u00e1 se budete muset zam\u011b\u0159it i na neindexovan\u00e9 lok\u00e1ln\u00ed \u010dasopisy. Pot\u0159ebujete glob\u00e1ln\u00ed i lok\u00e1ln\u00ed farmakovigilan\u010dn\u00ed expert\u00edzu \u2013 a p\u0159esn\u011b s t\u00edm v\u00e1m pom\u016f\u017eeme.<\/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=“{}“]

Management 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=“{}“]

Jakmile jsou va\u0161e produkty na trhu, mus\u00edte sledovat jejich bezpe\u010dnostn\u00ed profil a jeho v\u00fdvoj. D\u016fkladn\u00fd proces managementu sign\u00e1l\u016f v pr\u016fb\u011bhu cel\u00e9ho \u017eivotn\u00edho cyklu produktu je kl\u00ed\u010dovou sou\u010d\u00e1st\u00ed syst\u00e9mu farmakovigilance a mus\u00ed b\u00fdt definov\u00e1n i v PSMF. <\/p>

Jako dr\u017eitel rozhodnut\u00ed o registraci (MAH) odpov\u00edd\u00e1te za sledov\u00e1n\u00ed v\u0161ech informac\u00ed o bezpe\u010dnosti a posouzen\u00ed, zda pro v\u00e1\u0161 produkt nevyvstala nov\u00e1 rizika. M\u011bli byste revidovat individu\u00e1ln\u00ed hl\u00e1\u0161en\u00ed o bezpe\u010dnosti (ICSRs) a agregovan\u00e1 data ze v\u0161ech farmakovigilan\u010dn\u00edch aktivit 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=“{}“]

Typick\u00fd proces za\u010d\u00edn\u00e1 detekc\u00ed sign\u00e1lu a pokra\u010duje validac\u00ed a posouzen\u00edm potenci\u00e1ln\u00edho bezpe\u010dnostn\u00edho rizika. Pro management sign\u00e1l\u016f ale neexistuje univerz\u00e1ln\u00ed postup. <\/p>

Zva\u017ete relevantn\u00ed zdroje pro sv\u016fj produkt, frekvenci rutinn\u00edho hodnocen\u00ed sign\u00e1l\u016f, jejich prioritizaci a mnoho dal\u0161\u00edch faktor\u016f.<\/p>

Z praktick\u00e9ho hlediska doporu\u010dujeme posoudit, zda je pro va\u0161i situaci vhodn\u011bj\u0161\u00ed rutinn\u00ed manu\u00e1ln\u00ed proces, nebo pokro\u010dil\u00e1 anal\u00fdza dat a statistick\u00e9 metody s podporou technologi\u00ed.<\/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=“{}“]

Pot\u0159ebujete odbornou radu ohledn\u011b procesu a aktivit managementu sign\u00e1l\u016f? Kontaktujte n\u00e1s. <\/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=“

Monitoring literatury<\/h2>\n

Odborn\u00e9 \u010dasopisy jsou d\u016fle\u017eit\u00fdm zdrojem hl\u00e1\u0161en\u00ed o ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch a dal\u0161\u00edch informac\u00ed o bezpe\u010dnosti. V\u00fdrobci l\u00e9\u010div maj\u00ed povinnost zajistit d\u016fkladn\u00fd a pravideln\u00fd monitoring relevantn\u00ed literatury. <\/p>

Podle toho, na jak\u00fdch trz\u00edch p\u016fsob\u00edte, mus\u00edte sledovat glob\u00e1ln\u00ed datab\u00e1ze jako PubMed nebo Embase, ale mo\u017en\u00e1 i m\u00edstn\u00ed \u010dasopisy ve va\u0161em jazyce. Pot\u0159ebujete glob\u00e1ln\u00ed i lok\u00e1ln\u00ed farmakovigilan\u010dn\u00ed expert\u00edzu \u2013 a p\u0159esn\u011b s t\u00edm v\u00e1m pom\u016f\u017eeme.<\/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=“{}“]

Agregovan\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=“{}“]

Stejn\u011b jako u sledov\u00e1n\u00ed sign\u00e1l\u016f byste m\u011bli i p\u0159i monitorov\u00e1n\u00ed bezpe\u010dnostn\u00edho profilu sv\u00fdch produkt\u016f vyhodnocovat nov\u00e9 poznatky v periodick\u00fdch souhrnn\u00fdch zpr\u00e1v\u00e1ch. <\/p>\n

V EU a mnoha dal\u0161\u00edch zem\u00edch se tato zpr\u00e1va naz\u00fdv\u00e1 Pravideln\u00e1 zpr\u00e1va o hodnocen\u00ed bezpe\u010dnosti (PSUR) a obsahuje souhrn v\u0161ech informac\u00ed o bezpe\u010dnosti za dan\u00e9 obdob\u00ed. \u010cetnost pod\u00e1v\u00e1n\u00ed z\u00e1vis\u00ed hlavn\u011b na tom, jak je produkt star\u00fd.<\/p>\n

A ano, postar\u00e1me se o va\u0161i povinnost tyto periodick\u00e9 zpr\u00e1vy sestavit a odeslat.<\/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 promluvit<\/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 pot\u0159ebujete cokoli, t\u011b\u0161\u00edme se, a\u017e se spoj\u00edme. Napi\u0161te n\u00e1m a my se v\u00e1m obratem ozveme.<\/span><\/p>[\/et_pb_text][et_pb_button button_url=“\/cs\/?page_id=17253″ 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=“\/cs\/?page_id=17226″ button_text=“Napi\u0161te n\u00e1m“ 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 | Urho Kekkosen katu, 4-6 E, 00 100, Helsinky, Finsko | DI\u010c FI31367614 | contact@tepsivo.com\u00a0 <\/a>| +358 402 204 698 | Z\u00e1sady ochrany osobn\u00edch \u00fadaj\u016f<\/u><\/a><\/p>\n\n