{"id":17353,"date":"2021-09-29T12:35:30","date_gmt":"2021-09-29T12:35:30","guid":{"rendered":"https:\/\/www.tepsivo.com\/psani-lekarskych-zprav\/"},"modified":"2026-05-22T12:20:12","modified_gmt":"2026-05-22T12:20:12","slug":"psani-lekarskych-zprav","status":"publish","type":"page","link":"https:\/\/www.tepsivo.com\/cs\/psani-lekarskych-zprav\/","title":{"rendered":"Psan\u00ed l\u00e9ka\u0159sk\u00fdch zpr\u00e1v"},"content":{"rendered":"

[et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#eff1f4″ custom_padding=“||26px|||“ bottom_divider_style=“arrow2″ bottom_divider_color=“#ffffff“ bottom_divider_flip=“horizontal“ bottom_divider_height_tablet=““ bottom_divider_height_phone=“55px“ bottom_divider_height_last_edited=“on|phone“ global_colors_info=“{}“][et_pb_row custom_padding_last_edited=“on|phone“ _builder_version=“4.16″ max_width=“943px“ custom_margin_tablet=““ custom_margin_phone=“0px||||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“0px||0px||false|false“ custom_padding_tablet=““ custom_padding_phone=“5px||0px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_tablet=“<\/p>\n

Psan\u00ed l\u00e9ka\u0159sk\u00fdch zpr\u00e1v<\/h2>\n

“ content_phone=“<\/p>\n

Psan\u00ed l\u00e9ka\u0159sk\u00fdch zpr\u00e1v<\/h2>\n

“ content_last_edited=“on|phone“ _builder_version=“4.16″ 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=“0px||||false|false“ custom_margin_last_edited=“on|tablet“ custom_padding=“0px||||false|false“ custom_padding_tablet=“|0px||0px|false|false“ custom_padding_phone=“0px||||false|false“ 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=“{}“]<\/p>\n

Psan\u00ed l\u00e9ka\u0159sk\u00fdch zpr\u00e1v<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“3_5,2_5″ use_custom_gutter=“on“ gutter_width=“1″ custom_padding_last_edited=“on|phone“ _builder_version=“4.16″ width=“85%“ width_tablet=““ width_phone=“99%“ width_last_edited=“on|phone“ max_width=“990px“ custom_margin=“0px||||false|false“ custom_margin_tablet=““ custom_margin_phone=“0px|0px||0px|false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“0px||4px|58px|false|false“ custom_padding_tablet=““ custom_padding_phone=“|0px||0px|false|false“ module_alignment_tablet=““ module_alignment_phone=“center“ module_alignment_last_edited=“on|phone“ global_colors_info=“{}“][et_pb_column type=“3_5″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/medical-writing-transparent-background-from-vector.png“ title_text=“medical-writing-transparent-background-from-vector“ align=“center“ align_tablet=““ align_phone=“center“ align_last_edited=“on|phone“ disabled_on=“off|on|on“ _builder_version=“4.16″ width_tablet=““ width_phone=“100%“ width_last_edited=“on|phone“ max_height=“505px“ custom_margin=“7px||||false|false“ custom_padding=“9px|40px||0px|false|false“ custom_padding_tablet=““ custom_padding_phone=“|0px||0px|false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][\/et_pb_image][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“850px“ module_alignment=“center“ custom_margin=“|||0px|false|false“ custom_margin_tablet=““ custom_margin_phone=“|0px||0px|false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“17px|40px|17px|25px|false|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=“15px|25px||25px|false|true“ 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=“{}“]<\/p>\n

L\u00e9kopisn\u00e1 dokumentace v oblasti farmakovigilance je z\u00e1kladn\u00ed sou\u010d\u00e1st\u00ed na\u0161eho komplexn\u00edho farmakovigilan\u010dn\u00edho syst\u00e9mu. A\u0165 u\u017e hled\u00e1te outsourcing jednotliv\u00fdch slu\u017eeb psan\u00ed l\u00e9ka\u0159sk\u00fdch zpr\u00e1v, nebo komplexn\u00ed farmakovigilan\u010dn\u00ed \u0159e\u0161en\u00ed, ud\u011bl\u00e1te dob\u0159e, kdy\u017e se obr\u00e1t\u00edte na spole\u010dnost Tepsivo. <\/p>\n

Farmaceutick\u00e9 spole\u010dnosti, kter\u00e9 sv\u011b\u0159ily kompletn\u00ed \u0159\u00edzen\u00ed sv\u00fdch farmakovigilan\u010dn\u00edch povinnost\u00ed spole\u010dnosti Tepsivo, se nemus\u00ed starat o sledov\u00e1n\u00ed povinnost\u00ed t\u00fdkaj\u00edc\u00edch se psan\u00ed l\u00e9ka\u0159sk\u00fdch zpr\u00e1v a o to, jak\u00e9 dokumenty maj\u00ed sestavit, p\u0159edlo\u017eit \u00fa\u0159ad\u016fm a kdy. My se o n\u011b postar\u00e1me. <\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=“2_5″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/medical-writing-transparent-background-from-vector.png“ title_text=“medical-writing-transparent-background-from-vector“ align=“center“ disabled_on=“on|off|off“ _builder_version=“4.16″ max_height=“505px“ custom_margin=“7px||||false|false“ custom_padding=“9px|40px||0px|false|false“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row use_custom_gutter=“on“ gutter_width=“1″ _builder_version=“4.16″ width=“85%“ max_width=“990px“ custom_margin=“0px||||false|false“ custom_margin_tablet=““ custom_margin_phone=“||20px||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“0px||38px||false|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“1150px“ module_alignment=“center“ custom_margin=“|||0px|false|false“ custom_padding=“17px|0px|33px|0px|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=“{}“]<\/p>\n

A my se postar\u00e1me i o v\u00e1s. Sta\u010d\u00ed se s n\u00e1mi spojit a z\u00edskat dal\u0161\u00ed informace. <\/p>\n

[\/et_pb_text][et_pb_button button_url=“https:\/\/www.tepsivo.com\/cs\/kontakt\/“ button_text=“Kontaktujte n\u00e1s“ button_alignment=“center“ module_class=“secondary-button“ _builder_version=“4.16″ 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=“|0px||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=“4.16″ background_color=“#ffffff“ min_height=“271px“ custom_margin=“0px||0px||false|false“ custom_margin_tablet=“0px||||false|false“ custom_margin_phone=“0px||||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“24px||36px||false|false“ top_divider_color=“#eff1f4″ top_divider_height=“89px“ top_divider_flip=“horizontal“ bottom_divider_color=“#ffffff“ bottom_divider_height=“53px“ bottom_divider_flip=“horizontal“ global_colors_info=“{}“][et_pb_row column_structure=“2_5,3_5″ use_custom_gutter=“on“ gutter_width=“1″ _builder_version=“4.16″ width=“85%“ max_width=“850px“ custom_margin=“||0px||false|false“ custom_padding=“7px||17px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“2_5″ _builder_version=“4.16″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/Time-to-test-full-size-white-background-for-website.png“ title_text=“\u010cas na testov\u00e1n\u00ed pln\u00e9 velikosti b\u00edl\u00e9ho pozad\u00ed pro webov\u00e9 str\u00e1nky“ align=“center“ _builder_version=“4.16″ max_height=“274px“ custom_padding=“18px|17px|||false|false“ custom_padding_tablet=““ custom_padding_phone=“|0px||0px|false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][et_pb_column type=“3_5″ _builder_version=“4.16″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ module_alignment=“center“ custom_margin=“|||0px|false|false“ custom_padding=“27px|0px||0px|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=“{}“]<\/p>\n

V\u0161echny souhrnn\u00e9 zpr\u00e1vy, kter\u00e9 pot\u0159ebujete, ve spr\u00e1vn\u00fd \u010das<\/h4>\n

Na\u0161i z\u00e1kazn\u00edci v\u011bd\u00ed, \u017ee pe\u010dliv\u011b sledujeme, jak\u00e9 typy zpr\u00e1v je t\u0159eba p\u0159ipravit a kdy, abychom splnili jejich pr\u016fb\u011b\u017en\u00e9 regula\u010dn\u00ed povinnosti.<\/p>\n

M\u016f\u017ee se jednat o souhrnn\u00e9 zpr\u00e1vy, jako je Periodick\u00e1 aktualizovan\u00e1 zpr\u00e1va o bezpe\u010dnosti (PSUR) \/ Periodick\u00e1 zpr\u00e1va o hodnocen\u00ed p\u0159\u00ednos\u016f a rizik (PBRER) vy\u017eadovan\u00e1 v Evrop\u011b a n\u011bkter\u00fdch dal\u0161\u00edch zem\u00edch sv\u011bta nebo Periodick\u00e1 zpr\u00e1va o ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch l\u00e9\u010div (PADER) vy\u017eadovan\u00e1 FDA v USA.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#fafafa“ custom_padding=“78px||80px|||“ top_divider_style=“slant2″ top_divider_color=“#ffffff“ bottom_divider_style=“mountains2″ bottom_divider_color=“#eff1f4″ global_colors_info=“{}“][et_pb_row column_structure=“3_5,2_5″ use_custom_gutter=“on“ gutter_width=“1″ _builder_version=“4.16″ width=“85%“ max_width=“850px“ custom_margin=“0px||||false|false“ custom_padding=“0px||48px||false|false“ global_colors_info=“{}“][et_pb_column type=“3_5″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“600px“ module_alignment=“center“ custom_margin=“|||0px|false|false“ custom_margin_tablet=““ custom_margin_phone=““ custom_margin_last_edited=“on|phone“ custom_padding=“36px|12px||5px|false|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=“45px|||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=“{}“]<\/p>\n

Psan\u00ed a \u0159\u00edzen\u00ed pl\u00e1nu \u0159\u00edzen\u00ed<\/h4>\n

Pokud \u017e\u00e1d\u00e1te o novou registraci, mo\u017en\u00e1 budete muset p\u0159edlo\u017eit pl\u00e1n \u0159\u00edzen\u00ed rizik (RMP). To je samoz\u0159ejm\u011b sou\u010d\u00e1st\u00ed slu\u017eeb, kter\u00e9 v\u00e1m m\u016f\u017ee poskytnout spole\u010dnost Tepsivo v r\u00e1mci sv\u00e9ho kompletn\u00edho glob\u00e1ln\u00edho farmakovigilan\u010dn\u00edho \u0159e\u0161en\u00ed. <\/p>\n

S p\u0159ib\u00fdvaj\u00edc\u00edmi roky budeme sledovat, kdy bude pot\u0159eba pl\u00e1n RMP aktualizovat, a to za\u0159\u00edd\u00edme za v\u00e1s, v\u010detn\u011b p\u0159\u00edpravy souvisej\u00edc\u00ed zm\u011bny.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=“2_5″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/Businessman-reading-news-on-smartphone-transparent.png“ title_text=“Podnikatel-\u010dten\u00ed-novin-na-smartphonu-transparentn\u00ed“ _builder_version=“4.16″ max_width_tablet=““ max_width_phone=“79%“ max_width_last_edited=“on|phone“ module_alignment=“center“ custom_padding=“30px|0px|0px|20px|false|false“ custom_padding_tablet=““ custom_padding_phone=“|0px||0px|false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#eff1f4″ 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=“4px||35px||false|false“ top_divider_color=“#ffffff“ top_divider_height=“89px“ top_divider_flip=“horizontal“ bottom_divider_style=“mountains2″ bottom_divider_color=“#fafafa“ bottom_divider_height=“53px“ bottom_divider_flip=“horizontal“ global_colors_info=“{}“][et_pb_row _builder_version=“4.16″ background_color=“rgba(0,0,0,0)“ max_width=“1162px“ custom_padding=“0px|10px|25px|10px|false|false“ border_radii=“on|10px|10px|10px|10px“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_tablet=“<\/p>\n

Jak to d\u011bl\u00e1me?<\/h2>\n

<\/span><\/span><\/p>\n

“ content_phone=“<\/p>\n

Jak to d\u011bl\u00e1me?<\/h2>\n

<\/span><\/span><\/p>\n

“ content_last_edited=“off|desktop“ _builder_version=“4.16″ 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=“875px“ max_width_tablet=““ max_width_phone=““ max_width_last_edited=“on|tablet“ module_alignment=“center“ custom_margin=“0px||20px||false|false“ custom_margin_tablet=“0px|0px||0px|false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“15px||||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=“{}“]<\/p>\n

Jak to d\u011bl\u00e1me?<\/h2>\n

<\/span><\/span><\/p>\n

[\/et_pb_text][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“1172px“ module_alignment=“center“ custom_margin=“-11px||13px|0px|false|false“ custom_margin_tablet=““ custom_margin_phone=“|0px||0px|false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“17px|27px|3px|27px|false|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=“15px|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=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]<\/p>\n

D\u00edky na\u0161emu celkov\u00e9mu zam\u011b\u0159en\u00ed na efektivitu m\u016f\u017eeme v\u017edy zaru\u010dit, \u017ee v\u0161echny l\u00e9ka\u0159sk\u00e9 dokumenty budou p\u0159ipraveny rychle, s men\u0161\u00edm \u010dasov\u00fdm \u00fasil\u00edm (\u010dti s ni\u017e\u0161\u00edmi n\u00e1klady), \u017ee budou zachyceny v\u0161echny relevantn\u00ed informace a \u017ee v\u0161echny legislativn\u00ed po\u017eadavky budou spln\u011bny na 100 %, co\u017e zajist\u00ed nejvy\u0161\u0161\u00ed standard kvality.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.16″ background_color=“#ffffff“ max_width=“876px“ custom_padding=“30px||3px||false|false“ border_radii=“off|10px|10px||“ box_shadow_style=“preset1″ box_shadow_color=“rgba(0,0,0,0.1)“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“1.9em“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#7f7f7f“ header_4_font_size=“20px“ header_4_line_height=“1.7em“ max_width=“74%“ module_alignment=“center“ custom_padding=“|15px|0px|15px|false|false“ custom_padding_tablet=““ custom_padding_phone=“|5px||5px|false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“]<\/p>\n

Kdy\u017e ode\u0161lete souhrnnou zpr\u00e1vu nebo jin\u00fd typ dokumentu p\u0159ipraven\u00fd spole\u010dnost\u00ed Tepsivo, v\u00edte, \u017ee nebude odm\u00edtnut nebo vr\u00e1cen k p\u0159epracov\u00e1n\u00ed.<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ use_custom_gutter=“on“ gutter_width=“1″ _builder_version=“4.16″ background_color=“#ffffff“ max_width=“876px“ custom_margin=“-7px||0px||false|false“ custom_padding=“12px||0px||false|false“ border_radii=“off|10px|10px|10px|10px“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_image src=“https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/tepsivo-automated-pv-solution-screenshot.png“ title_text=“tepsivo-automated-pv-solution-screenshot“ _builder_version=“4.16″ max_width=“89%“ module_alignment=“center“ custom_margin=“1px||0px||false|false“ custom_padding=“72px||||false|false“ custom_padding_tablet=““ custom_padding_phone=“5px||0px||false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ custom_padding=“32px|55px|28px||false|false“ custom_padding_tablet=““ custom_padding_phone=“5px|25px||25px|false|true“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“]<\/p>\n

Pro\u010d? V na\u0161em glob\u00e1ln\u00edm farmakovigilan\u010dn\u00edm syst\u00e9mu, kter\u00fd je pln\u011b provozov\u00e1n prost\u0159ednictv\u00edm na\u0161\u00ed jedine\u010dn\u00e9 intern\u00ed platformy Tepsivo, jsou v\u0161echny relevantn\u00ed bezpe\u010dnostn\u00ed \u00fadaje a ve\u0161ker\u00e9 aktivity souvisej\u00edc\u00ed s farmakovigilanc\u00ed v\u017edy zaznamen\u00e1ny na jednom centr\u00e1ln\u00edm m\u00edst\u011b – to je platforma Tepsivo. <\/p>\n

D\u00edky tomuto inovativn\u00edmu a v sou\u010dasn\u00e9 dob\u011b jedine\u010dn\u00e9mu, ale velmi jednoduch\u00e9mu p\u0159\u00edstupu m\u016f\u017eeme snadno odstranit ve\u0161kerou administrativu a otravnou pr\u00e1ci spojenou se shroma\u017e\u010fov\u00e1n\u00edm zdrojov\u00fdch dat pro va\u0161e l\u00e9ka\u0159sk\u00e9 psan\u00ed a dokonce i starosti o r\u016fzn\u00e9 verze zpr\u00e1v nebo o to, kde jsou fin\u00e1ln\u00ed dokumenty ulo\u017eeny a udr\u017eov\u00e1ny pro aktualizace.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.16″ background_color=“rgba(0,0,0,0)“ max_width=“1162px“ custom_padding=“0px|10px|0px|10px|false|false“ border_radii=“on|10px|10px|10px|10px“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“1041px“ module_alignment=“center“ custom_margin=“-11px||13px|0px|false|false“ custom_margin_tablet=““ custom_margin_phone=“25px||||false|false“ custom_margin_last_edited=“on|phone“ custom_padding=“50px|0px|3px|0px|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=“{}“]<\/p>\n

V\u0161echny informace t\u00fdkaj\u00edc\u00ed se bezpe\u010dnosti jsou v\u017edy k dispozici MAH a v\u0161em osob\u00e1m v syst\u00e9mu farmakovigilance, a to na platform\u011b Tepsivo. P\u0159i retrospektivn\u00edm p\u0159ezkumu a anal\u00fdz\u00e1ch sign\u00e1l\u016f lze v\u0161echny tyto \u00fadaje velmi snadno propojit s individu\u00e1ln\u00edm hl\u00e1\u0161en\u00edm sign\u00e1lu a tot\u00e9\u017e plat\u00ed pro pravideln\u00e9 souhrnn\u00e9 hl\u00e1\u0161en\u00ed, jako je PSUR. To v\u0161e p\u0159i eliminaci nekone\u010dn\u00fdch hodin za po\u0159\u00edzen\u00edm dat a jejich p\u0159esunem na m\u00edsto, kde je lze analyzovat a n\u00e1sledn\u011b zachytit v jednom reportu. <\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.16″ width=“85%“ max_width=“850px“ custom_margin=“0px||0px||false|false“ custom_padding=“7px||30px|0px|false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text content_phone=“<\/p>\n

Obra\u0165te se na n\u00e1s a my v\u00e1m na
\nuk\u00e1\u017eeme, jak to d\u011bl\u00e1me.<\/a><\/p>\n

“ content_last_edited=“off|desktop“ _builder_version=“4.16″ header_4_font=“Montserrat|600|||||||“ header_4_font_size=“20px“ header_4_line_height=“1.7em“ custom_margin=“||0px||false|false“ custom_padding=“0px||15px||false|false“ global_colors_info=“{}“]<\/p>\n

Obra\u0165te se na n\u00e1s a my v\u00e1m uk\u00e1\u017eeme, jak to d\u011bl\u00e1me.<\/a><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#fafafa“ custom_padding=“22px||2px|||“ top_divider_color=“#ffffff“ top_divider_flip=“horizontal“ bottom_divider_style=“mountains2″ bottom_divider_color=“#ffffff“ bottom_divider_flip=“horizontal“ global_colors_info=“{}“][et_pb_row _builder_version=“4.16″ background_color=“rgba(0,0,0,0)“ max_width=“1162px“ custom_padding=“0px|10px|25px|10px|false|false“ border_radii=“on|10px|10px|10px|10px“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_tablet=“<\/p>\n

Individu\u00e1ln\u00ed l\u00e9ka\u0159sk\u00e9 spisovatelsk\u00e9 slu\u017eby<\/h2>\n

<\/span><\/span><\/p>\n

“ content_phone=“<\/p>\n

Individu\u00e1ln\u00ed l\u00e9ka\u0159sk\u00e9 spisovatelsk\u00e9 slu\u017eby<\/h2>\n

<\/span><\/span><\/p>\n

“ content_last_edited=“off|desktop“ _builder_version=“4.16″ 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=“875px“ max_width_tablet=““ max_width_phone=““ max_width_last_edited=“on|tablet“ module_alignment=“center“ custom_margin=“0px||20px||false|false“ custom_margin_tablet=“0px|0px||0px|false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“15px||||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=“{}“]<\/p>\n

Individu\u00e1ln\u00ed l\u00e9ka\u0159sk\u00e9 spisovatelsk\u00e9 slu\u017eby<\/h2>\n

<\/span><\/span><\/p>\n

[\/et_pb_text][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“1172px“ module_alignment=“center“ custom_margin=“-11px||13px|0px|false|false“ custom_padding=“17px|27px|3px|27px|false|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=“15px|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=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]<\/p>\n

Nebo m\u00e1te specifickou pot\u0159ebu individu\u00e1ln\u00ed podpory v oblasti farmakovigilance?
Dejte n\u00e1m v\u011bd\u011bt, jak\u00e9 dokumenty pot\u0159ebujete sepsat, a my to pro v\u00e1s tak\u00e9 za\u0159\u00edd\u00edme.<\/p>\n

[\/et_pb_text][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“1172px“ module_alignment=“center“ custom_margin=“-11px||82px|0px|false|false“ custom_padding=“17px|27px|3px|27px|false|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=“15px|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=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]<\/p>\n

P\u0159\u00edkladem m\u016f\u017ee b\u00fdt:<\/p>\n

\u2713 Periodick\u00e1 aktualizovan\u00e1 zpr\u00e1va o bezpe\u010dnosti (PSUR)
\u2713 Periodick\u00e1 zpr\u00e1va o hodnocen\u00ed p\u0159\u00ednos\u016f a rizik (PBRER)
\u2713 Periodick\u00e1 zpr\u00e1va o ne\u017e\u00e1douc\u00edch zku\u0161enostech s l\u00e9\u010divy (PADER)
\u2713 Pl\u00e1n \u0159\u00edzen\u00ed rizik (RMP)<\/strong><\/p>\n

A mo\u017en\u00e1 pot\u0159ebujete ps\u00e1t l\u00e9ka\u0159sk\u00e9 texty v klinick\u00fdch studi\u00edch? M\u016f\u017eeme v\u00e1m pomoci s: <\/p>\n

\u2713 Protokol studie
\u2713 Pl\u00e1n \u0159\u00edzen\u00ed bezpe\u010dnosti
\u2713 Bro\u017eury pro zkou\u0161ej\u00edc\u00edho
\u2713 Formul\u00e1\u0159e informovan\u00e9ho souhlasu<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#ffffff“ custom_padding=“0px||13px|||“ global_colors_info=“{}“][et_pb_row _builder_version=“4.16″ custom_padding=“1px||1px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text content_tablet=“<\/p>\n

V\u00fdzkum na vy\u017e\u00e1d\u00e1n\u00ed<\/h2>\n

<\/span><\/span><\/p>\n

“ content_phone=“<\/p>\n

V\u00fdzkum na vy\u017e\u00e1d\u00e1n\u00ed<\/h2>\n

<\/span><\/span><\/p>\n

“ content_last_edited=“off|desktop“ _builder_version=“4.16″ 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=“875px“ max_width_tablet=““ max_width_phone=““ max_width_last_edited=“on|tablet“ module_alignment=“center“ custom_margin=“0px||20px||false|false“ custom_margin_tablet=“0px|0px||0px|false|false“ custom_margin_phone=““ custom_margin_last_edited=“on|tablet“ custom_padding=“15px||||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=“{}“]<\/p>\n

V\u00fdzkum na vy\u017e\u00e1d\u00e1n\u00ed<\/h2>\n

<\/span><\/span><\/p>\n

[\/et_pb_text][et_pb_text content_last_edited=“off|desktop“ _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_font=“||||||||“ header_4_font=“Montserrat|600|||||||“ header_4_text_color=“#312533″ header_4_font_size=“20px“ header_4_line_height=“1.6em“ text_orientation=“justified“ max_width=“837px“ module_alignment=“center“ custom_margin=“-11px||13px|0px|false|false“ custom_padding=“17px|27px|3px|27px|false|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=“15px|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=“center“ text_orientation_phone=“center“ text_orientation_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]<\/p>\n

M\u016f\u017eeme tak\u00e9 prov\u00e9st specifick\u00fd v\u00fdzkum na vy\u017e\u00e1d\u00e1n\u00ed a p\u0159ipravit zpr\u00e1vu nebo \u010dl\u00e1nek.<\/p>\n

Rychl\u00fdm p\u0159\u00edkladem ad hoc anal\u00fdzy je na\u0161e \u0161et\u0159en\u00ed hl\u00e1\u0161en\u00e9ho n\u00e1r\u016fstu ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f l\u00e9kov\u00e9ho trh\u00e1ku, kter\u00e9 se dostalo do zpr\u00e1v, ale jak ukazuje na\u0161e kritick\u00e1 anal\u00fdza dat, pravd\u011bpodobn\u011b nem\u00e1 \u017e\u00e1dn\u00fd v\u00fdznam:
„Anal\u00fdza potenci\u00e1ln\u00edho bezpe\u010dnostn\u00edho sign\u00e1lu“, kterou provedl Martti Ahtola <\/a> <\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#0c9cd1″ use_background_color_gradient=“on“ background_color_gradient_stops=“#F4F5F7 0%|#F4F5F7 100%“ background_color_gradient_start=“#F4F5F7″ background_color_gradient_end=“#F4F5F7″ custom_margin=“-1px||||false|false“ custom_padding=“0px||21px||false|false“ top_divider_style=“mountains2″ top_divider_color=“#ffffff“ top_divider_height=“75px“ top_divider_flip=“horizontal“ global_colors_info=“{}“][et_pb_row _builder_version=“4.16″ custom_padding=“101px|||||“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ custom_padding=“|||“ global_colors_info=“{}“ custom_padding__hover=“|||“][et_pb_text _builder_version=“4.16″ 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=“{}“]<\/p>\n

Poj\u010fme si popov\u00eddat<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=“4.16″ text_font=“Montserrat||||||||“ text_line_height=“2em“ header_line_height=“1.5em“ text_orientation=“center“ global_colors_info=“{}“]<\/p>\n

A\u0165 u\u017e jsou tv\u00e9 pot\u0159eby jak\u00e9koli, t\u011b\u0161\u00edme se na kontakt s tebou.
\nNev\u00e1hej n\u00e1m napsat zpr\u00e1vu a my se ti hned ozveme.<\/p>\n

[\/et_pb_text][et_pb_button button_url=“https:\/\/www.tepsivo.com\/cs\/zarezervujte-si-bezplatnou-15minutovou-konzultaci\/“ button_text=“Zarezervujte si 15minutovou konzultaci ZDARMA“ button_alignment=“center“ module_class=“primary-button“ _builder_version=“4.16″ 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\/cs\/kontakt\/“ button_text=“Napi\u0161te zpr\u00e1vu“ button_alignment=“center“ module_class=“secondary-button“ _builder_version=“4.16″ 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=“4.16″ 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=“4.16″ custom_padding=“15px||14px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text _builder_version=“4.27.4″ text_font=“Montserrat||||||||“ text_orientation=“center“ hover_enabled=“0″ global_colors_info=“{}“ sticky_enabled=“0″]<\/p>\n

Tepsivo Oy | Haartmaninkatu 4, Building 14, 00290, Helsinki, Finsko<\/span> | DI\u010c FI31367614 | contact@tepsivo.com <\/a>| +358 402 204 698 | Z\u00e1sady ochrany osobn\u00edch \u00fadaj\u016f<\/u><\/a><\/p>\n

\n