{"id":17426,"date":"2021-09-20T17:03:28","date_gmt":"2021-09-20T17:03:28","guid":{"rendered":"https:\/\/www.tepsivo.com\/hlavni-soubor-farmakovigilancniho-systemu\/"},"modified":"2026-08-16T10:55:33","modified_gmt":"2026-08-16T10:55:33","slug":"hlavni-soubor-farmakovigilancniho-systemu","status":"publish","type":"page","link":"https:\/\/www.tepsivo.com\/cs\/hlavni-soubor-farmakovigilancniho-systemu\/","title":{"rendered":"Hlavn\u00ed soubor syst\u00e9mu farmakovigilance"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#eff1f4&#8243; custom_padding=&#8220;||21px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; max_width=&#8220;943px&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;1px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_tablet=&#8220;<\/p>\n<h2 style=%22font-weight: 500;%22>Syst\u00e9mov\u00fd hlavn\u00ed soubor farmakovigilance (PSMF) <\/h2>\n<p style=%22font-weight: 400;%22>Syst\u00e9mov\u00fd hlavn\u00ed soubor farmakovigilance (PSMF) je kl\u00ed\u010dov\u00fd legislativn\u00ed dokument. Mus\u00edte ho vytvo\u0159it a pravideln\u011b aktualizovat, abyste p\u0159i inspekci mohli dolo\u017eit, jak v\u00e1\u0161 syst\u00e9m farmakovigilance funguje.<\/p>\n<p>&#8220; content_phone=&#8220;<\/p>\n<h2 style=%22font-weight: 500;%22>Syst\u00e9mov\u00fd hlavn\u00ed soubor farmakovigilance (PSMF) <\/h2>\n<p style=%22font-weight: 400;%22>Syst\u00e9mov\u00fd hlavn\u00ed soubor farmakovigilance (PSMF) je kl\u00ed\u010dov\u00fd legislativn\u00ed dokument. Mus\u00edte ho vytvo\u0159it a pravideln\u011b aktualizovat, abyste p\u0159i inspekci mohli dolo\u017eit, jak v\u00e1\u0161 syst\u00e9m farmakovigilance funguje.<\/p>\n<p>&#8220; content_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; ul_font=&#8220;||||||||&#8220; ol_font=&#8220;||||||||&#8220; header_font=&#8220;Montserrat||||||||&#8220; header_2_font=&#8220;Montserrat|700|||||||&#8220; header_2_text_color=&#8220;#312533&#8243; header_2_font_size=&#8220;36px&#8220; header_2_line_height=&#8220;1.6em&#8220; header_3_font=&#8220;Merriweather|700|||||||&#8220; header_3_text_color=&#8220;#ffc47c&#8220; header_3_font_size=&#8220;18px&#8220; header_3_line_height=&#8220;1.8em&#8220; header_4_font=&#8220;||||||||&#8220; header_5_font=&#8220;||||||||&#8220; header_6_font=&#8220;||||||||&#8220; text_orientation=&#8220;center&#8220; max_width_tablet=&#8220;&#8220; max_width_phone=&#8220;&#8220; max_width_last_edited=&#8220;on|tablet&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;0px|0px||0px|false|false&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;0px||||false|false&#8220; custom_padding_tablet=&#8220;|0px||0px|false|false&#8220; custom_padding_phone=&#8220;0px||||false|false&#8220; custom_padding_last_edited=&#8220;on|tablet&#8220; header_2_font_size_tablet=&#8220;&#8220; header_2_font_size_phone=&#8220;28px&#8220; header_2_font_size_last_edited=&#8220;on|phone&#8220; header_3_font_size_tablet=&#8220;&#8220; header_3_font_size_phone=&#8220;14px&#8220; header_3_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2 style=\"font-weight: 500;\">Syst\u00e9mov\u00fd hlavn\u00ed soubor farmakovigilance (PSMF) <\/h2>\n<p style=\"font-weight: 400;\">Syst\u00e9mov\u00fd hlavn\u00ed soubor farmakovigilance (PSMF) je kl\u00ed\u010dov\u00fd legislativn\u00ed dokument. Mus\u00edte ho vytvo\u0159it a pravideln\u011b aktualizovat, abyste p\u0159i inspekci mohli dolo\u017eit, jak v\u00e1\u0161 syst\u00e9m farmakovigilance funguje.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;2_3,1_3&#8243; _builder_version=&#8220;4.16&#8243; width=&#8220;85%&#8220; max_width=&#8220;850px&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_padding=&#8220;0px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;2_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/09\/psmf-2.png&#8220; title_text=&#8220;psmf&#8220; align=&#8220;center&#8220; disabled_on=&#8220;off|on|on&#8220; _builder_version=&#8220;4.16&#8243; max_height=&#8220;307px&#8220; max_height_tablet=&#8220;&#8220; max_height_phone=&#8220;202px&#8220; max_height_last_edited=&#8220;on|phone&#8220; custom_margin=&#8220;29px||||false|false&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;5px||10px||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;5px||0px||false|false&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][et_pb_text content_tablet=&#8220;&#8220; content_phone=&#8220;<\/p>\n<h4 style=%22font-weight: 500;%22>Jak ho pro v\u00e1s<br \/>\nvytvo\u0159\u00edme?  <\/h4>\n<p style=%22font-weight: 400;%22>Sestaven\u00ed PSMF nen\u00ed \u017e\u00e1dn\u00e1 v\u011bda, to podstatn\u00e9 je v jeho obsahu. Pokud pot\u0159ebujete nastavit nov\u00fd syst\u00e9m farmakovigilance, ozv\u011bte se n\u00e1m. D\u00edky na\u0161\u00ed \u0161ablon\u011b, kter\u00e1 popisuje n\u00e1\u0161 glob\u00e1ln\u00ed syst\u00e9m farmakovigilance, budete m\u00edt PSMF hotov\u00fd raz dva. <\/p>\n<p style=%22font-weight: 400;%22>Sta\u010d\u00ed s n\u00e1mi doplnit p\u00e1r detail\u016f, jako je v\u00e1\u0161 vnit\u0159n\u00ed syst\u00e9m kvality, organiza\u010dn\u00ed struktura, l\u00e9ka\u0159sk\u00e9 informace, partne\u0159i a dal\u0161\u00ed oblasti. <\/p>\n<p>&#8220; content_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; header_font=&#8220;||||||||&#8220; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.6em&#8220; text_orientation=&#8220;justified&#8220; max_width=&#8220;600px&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;||43px|0px|false|false&#8220; custom_padding=&#8220;36px|0px||0px|false|false&#8220; custom_padding_tablet=&#8220;|||0px|false|false&#8220; custom_padding_phone=&#8220;15px|||0px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; header_4_font_size_phone=&#8220;20px&#8220; header_4_font_size_last_edited=&#8220;off|desktop&#8220; text_orientation_tablet=&#8220;center&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500;\">Jak ho pro v\u00e1s vytvo\u0159\u00edme?  <\/h4>\n<p style=\"font-weight: 400;\">Sestaven\u00ed PSMF nen\u00ed \u017e\u00e1dn\u00e1 v\u011bda, to podstatn\u00e9 je v jeho obsahu. Pokud pot\u0159ebujete nastavit nov\u00fd syst\u00e9m farmakovigilance, ozv\u011bte se n\u00e1m. D\u00edky na\u0161\u00ed \u0161ablon\u011b, kter\u00e1 popisuje n\u00e1\u0161 glob\u00e1ln\u00ed syst\u00e9m farmakovigilance, budete m\u00edt PSMF hotov\u00fd raz dva. <\/p>\n<p style=\"font-weight: 400;\">Sta\u010d\u00ed s n\u00e1mi doplnit p\u00e1r detail\u016f, jako je v\u00e1\u0161 vnit\u0159n\u00ed syst\u00e9m kvality, organiza\u010dn\u00ed struktura, l\u00e9ka\u0159sk\u00e9 informace, partne\u0159i a dal\u0161\u00ed oblasti. <\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8220;\/cs\/?page_id=17226&#8243; button_text=&#8220;Kontaktujte n\u00e1s&#8220; button_alignment=&#8220;left&#8220; button_alignment_tablet=&#8220;&#8220; button_alignment_phone=&#8220;center&#8220; button_alignment_last_edited=&#8220;on|phone&#8220; module_class=&#8220;secondary-button&#8220; _builder_version=&#8220;4.16&#8243; custom_button=&#8220;on&#8220; button_text_size=&#8220;16px&#8220; button_text_color=&#8220;#ffffff&#8220; button_bg_color=&#8220;#b5302f&#8220; button_border_width=&#8220;2px&#8220; button_border_color=&#8220;#b5302f&#8220; button_border_radius=&#8220;19px&#8220; button_font=&#8220;Montserrat||||||||&#8220; button_use_icon=&#8220;off&#8220; custom_margin=&#8220;|10px||0px|false|false&#8220; custom_padding=&#8220;9px|80px|9px|80px|false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;9px|45px|9px|45px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_button][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/09\/psmf-2.png&#8220; title_text=&#8220;psmf&#8220; align=&#8220;center&#8220; disabled_on=&#8220;on|off|off&#8220; _builder_version=&#8220;4.16&#8243; max_height=&#8220;307px&#8220; custom_margin=&#8220;29px||||false|false&#8220; custom_padding=&#8220;12px|||||&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#ffffff&#8220; min_height=&#8220;445px&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;0px||||false|false&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;57px||4px||false|false&#8220; top_divider_style=&#8220;slant2&#8243; top_divider_color=&#8220;#eff1f4&#8243; top_divider_height=&#8220;89px&#8220; top_divider_flip=&#8220;horizontal&#8220; top_divider_height_tablet=&#8220;&#8220; top_divider_height_phone=&#8220;55px&#8220; top_divider_height_last_edited=&#8220;on|phone&#8220; bottom_divider_color=&#8220;#ffffff&#8220; bottom_divider_height=&#8220;53px&#8220; bottom_divider_flip=&#8220;horizontal&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row column_structure=&#8220;2_5,3_5&#8243; use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; width=&#8220;85%&#8220; max_width=&#8220;850px&#8220; custom_margin=&#8220;||||false|false&#8220; custom_padding=&#8220;7px||50px|0px|false|false&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;2_5&#8243; _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;|||&#8220; global_colors_info=&#8220;{}&#8220; custom_padding__hover=&#8220;|||&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/09\/when-do-you-need-psmf.png&#8220; title_text=&#8220;when-do-you-need-psmf&#8220; align=&#8220;center&#8220; _builder_version=&#8220;4.16&#8243; max_height=&#8220;274px&#8220; max_height_tablet=&#8220;&#8220; max_height_phone=&#8220;198px&#8220; max_height_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;70px||||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;15px||||false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8220;3_5&#8243; _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;|||&#8220; global_colors_info=&#8220;{}&#8220; custom_padding__hover=&#8220;|||&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; header_font=&#8220;||||||||&#8220; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.6em&#8220; text_orientation=&#8220;justified&#8220; max_width=&#8220;600px&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;|||0px|false|false&#8220; custom_padding=&#8220;66px|0px||0px|false|false&#8220; custom_padding_tablet=&#8220;|||0px|false|false&#8220; custom_padding_phone=&#8220;15px|||0px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; header_4_font_size_phone=&#8220;20px&#8220; header_4_font_size_last_edited=&#8220;off|desktop&#8220; text_orientation_tablet=&#8220;center&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500;\">Kdy PSMF pot\u0159ebujete?<\/h4>\n<p style=\"font-weight: 400;\">Pokud uv\u00e1d\u00edte na trh sv\u016fj prvn\u00ed l\u00e9\u010div\u00fd p\u0159\u00edpravek, mus\u00edte m\u00edt syst\u00e9m farmakovigilance p\u0159ipraven\u00fd u\u017e p\u0159i pod\u00e1n\u00ed \u017e\u00e1dosti o registraci (MAA). A proto\u017ee PSMF je p\u0159ehledem tohoto syst\u00e9mu, m\u011bl by b\u00fdt hotov\u00fd pr\u00e1v\u011b v dob\u011b pod\u00e1n\u00ed \u017e\u00e1dosti. <\/p>\n<p style=\"font-weight: 400;\">Pro samotnou \u017e\u00e1dost o registraci budete pot\u0159ebovat souhrn syst\u00e9mu farmakovigilance. Ten mus\u00ed obsahovat \u010d\u00edslo PSMF, jeho um\u00edst\u011bn\u00ed a \u00fadaje o va\u0161\u00ed QPPV. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; custom_padding_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#fafafa&#8220; custom_padding=&#8220;78px||21px|||&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;||0px||false|false&#8220; top_divider_style=&#8220;slant2&#8243; top_divider_color=&#8220;#ffffff&#8220; top_divider_height_tablet=&#8220;&#8220; top_divider_height_phone=&#8220;55px&#8220; top_divider_height_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row column_structure=&#8220;2_3,1_3&#8243; _builder_version=&#8220;4.16&#8243; width=&#8220;85%&#8220; max_width=&#8220;850px&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;||0px||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;0px||0px||false|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;2_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/world-map-with-almost-transparent-background.png&#8220; title_text=&#8220;world-map-with-almost-transparent-background&#8220; align_tablet=&#8220;&#8220; align_phone=&#8220;center&#8220; align_last_edited=&#8220;on|phone&#8220; disabled_on=&#8220;off|on|on&#8220; _builder_version=&#8220;4.16&#8243; max_height_tablet=&#8220;&#8220; max_height_phone=&#8220;193px&#8220; max_height_last_edited=&#8220;on|phone&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;||5px||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;95px||||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;5px||0px||false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; header_font=&#8220;||||||||&#8220; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.6em&#8220; text_orientation=&#8220;justified&#8220; max_width=&#8220;600px&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;|||0px|false|false&#8220; custom_padding=&#8220;36px|0px||0px|false|false&#8220; custom_padding_tablet=&#8220;|||0px|false|false&#8220; custom_padding_phone=&#8220;15px|||0px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; header_4_font_size_phone=&#8220;20px&#8220; header_4_font_size_last_edited=&#8220;off|desktop&#8220; text_orientation_tablet=&#8220;center&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500;\">Kde ho pot\u0159ebujete?<\/h4>\n<p style=\"font-weight: 400;\">PSMF vy\u017eaduj\u00ed p\u0159edev\u0161\u00edm evrop\u0161t\u00ed z\u00e1konod\u00e1rci. Pokud p\u016fsob\u00edte alespo\u0148 na jednom evropsk\u00e9m trhu, mus\u00edte m\u00edt syst\u00e9mov\u00fd hlavn\u00ed soubor farmakovigilance zpracovan\u00fd.<\/p>\n<p style=\"font-weight: 400;\">Krom\u011b toho m\u016f\u017eete pot\u0159ebovat lok\u00e1ln\u00ed PSMF i v dal\u0161\u00edch zem\u00edch, nap\u0159\u00edklad ve Francii, Sa\u00fadsk\u00e9 Ar\u00e1bii nebo nov\u011b ve Spojen\u00e9m kr\u00e1lovstv\u00ed.<\/p>\n<p style=\"font-weight:400;\">PSMF pro Spojen\u00e9 kr\u00e1lovstv\u00ed je po brexitu novou povinnost\u00ed a je sou\u010d\u00e1st\u00ed na\u0161ich glob\u00e1ln\u00edch slu\u017eeb. Pod\u00edvejte se, <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/pharmacovigilance-services\/brexit-pharmacovigilance-in-the-uk\/\">co pro v\u00e1s m\u016f\u017eeme ve Spojen\u00e9m kr\u00e1lovstv\u00ed ud\u011blat<\/a> a jak se zorientovat v po\u017eadavc\u00edch MHRA na farmakovigilanci.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/world-map-with-almost-transparent-background.png&#8220; title_text=&#8220;world-map-with-almost-transparent-background&#8220; disabled_on=&#8220;on|off|off&#8220; _builder_version=&#8220;4.16&#8243; max_height_tablet=&#8220;&#8220; max_height_phone=&#8220;193px&#8220; max_height_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;95px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#fafafa&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;0px||||false|false&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;36px||2px||false|false&#8220; top_divider_color=&#8220;#ffffff&#8220; top_divider_height=&#8220;89px&#8220; top_divider_flip=&#8220;horizontal&#8220; bottom_divider_color=&#8220;#ffffff&#8220; bottom_divider_height=&#8220;53px&#8220; bottom_divider_flip=&#8220;horizontal&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row custom_padding_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#ffffff&#8220; max_width=&#8220;876px&#8220; custom_padding=&#8220;30px||3px||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;&#8220; border_radii=&#8220;off|10px|10px||&#8220; box_shadow_style=&#8220;preset1&#8243; box_shadow_color=&#8220;rgba(0,0,0,0.1)&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.4em&#8220; max_width=&#8220;100%&#8220; custom_padding=&#8220;|15px||15px|false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;|29px||29px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500; text-align: center;\">Jak zajist\u00edme aktu\u00e1lnost?  <\/h4>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;1_2,1_2&#8243; use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#ffffff&#8220; max_width=&#8220;876px&#8220; custom_padding=&#8220;1px||12px||false|false&#8220; border_radii=&#8220;off||||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/tepsivo-automated-pv-solution-screenshot.png&#8220; title_text=&#8220;tepsivo-automated-pv-solution-screenshot&#8220; _builder_version=&#8220;4.16&#8243; max_width=&#8220;89%&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;-13px||||false|false&#8220; custom_padding=&#8220;0px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;0px|0px||0px|false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;17px|55px|12px||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;5px|29px||29px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"text-align: justify;\">V syst\u00e9mu Tepsivo PV se na\u0161i EU QPPV jednodu\u0161e\u00a0<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">p\u0159ihl\u00e1s\u00ed<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">do<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">\u00a0na\u0161\u00ed vlastn\u00ed<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2 SCXW69252997 BCX0\">platformy Tepsivo<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">\u00a0a maj\u00ed okam\u017eit\u00fd p\u0159ehled o v\u0161em<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">, v\u010detn\u011b mo\u017enosti p\u0159\u00edmo komentovat jakoukoli aktivitu.\u00a0<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">podle vlastn\u00edho uv\u00e1\u017een\u00ed.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;|55px|||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;|29px||29px|false|false&#8220; custom_padding_last_edited=&#8220;on|desktop&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"text-align: justify;\"><span class=\"NormalTextRun SCXW23593537 BCX0\">Z\u00e1konn\u00fd po\u017eadavek na p\u0159\u00edstup k PSMF a dohled nad v\u0161emi \u00fakoly farmakovigilance je\u00a0<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">zaru\u010den\u00a0<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">za v\u0161ech okolnost\u00ed<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">. U\u0161et\u0159\u00edte des\u00edtky hodin administrativy m\u011bs\u00ed\u010dn\u011b a v\u00e1\u0161 EU QPPV bude spokojen\u011bj\u0161\u00ed<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">, efektivn\u011bj\u0161\u00ed a zam\u011b\u0159en\u00fd na to, co je d\u016fle\u017eit\u00e9 a na co je vy\u0161kolen.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;2&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#ffffff&#8220; max_width=&#8220;876px&#8220; custom_margin=&#8220;-33px||||false|false&#8220; custom_padding=&#8220;1px||29px||false|false&#8220; border_radii=&#8220;off|||10px|10px&#8220; box_shadow_style=&#8220;preset1&#8243; box_shadow_vertical=&#8220;16px&#8220; box_shadow_blur=&#8220;14px&#8220; box_shadow_color=&#8220;rgba(0,0,0,0.1)&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_tablet=&#8220;&#8220; content_phone=&#8220;<\/p>\n<p style=%22font-weight: 400;%22>P\u0159e\u010dt\u011bte si v\u00edce o na\u0161em<br \/>\n<a style=%22color: #b5302f; font-weight: 500;%22 href=%22\/cs\/?page_id=18739%22>komplexn\u00edm glob\u00e1ln\u00edm syst\u00e9mu farmakovigilance<\/a><br \/>\na o tom, jak jej spravujeme prost\u0159ednictv\u00edm na\u0161\u00ed jedine\u010dn\u00e9 <a style=%22color: #b5302f; font-weight: 500;%22 href=%22\/cs\/?page_id=17670%22>platformy Tepsivo<\/a>.<\/p>\n<p>&#8220; content_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;1.6em&#8220; ul_font=&#8220;||||||||&#8220; ol_font=&#8220;||||||||&#8220; header_font=&#8220;||||||||&#8220; header_2_font=&#8220;Merriweather|700|||||||&#8220; header_2_font_size=&#8220;36px&#8220; header_2_line_height=&#8220;1.6em&#8220; header_3_font=&#8220;Merriweather|700|||||||&#8220; header_3_text_color=&#8220;#ffc47c&#8220; header_3_font_size=&#8220;18px&#8220; header_3_line_height=&#8220;1.8em&#8220; header_4_font=&#8220;||||||||&#8220; header_5_font=&#8220;||||||||&#8220; header_6_font=&#8220;||||||||&#8220; text_orientation=&#8220;center&#8220; max_width=&#8220;80%&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;1px|||||&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;45px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; header_2_font_size_tablet=&#8220;&#8220; header_2_font_size_phone=&#8220;20px&#8220; header_2_font_size_last_edited=&#8220;on|phone&#8220; header_3_font_size_tablet=&#8220;&#8220; header_3_font_size_phone=&#8220;14px&#8220; header_3_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"font-weight: 400;\">P\u0159e\u010dt\u011bte si v\u00edce o na\u0161em <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/cs\/pharmacovigilance-services\/globalni-farmakovigilancni-system\/\">komplexn\u00edm glob\u00e1ln\u00edm syst\u00e9mu farmakovigilance<\/a><br \/>\na o tom, jak jej spravujeme prost\u0159ednictv\u00edm na\u0161\u00ed jedine\u010dn\u00e9 <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/cs\/sluzby-a-software-pro-farmakovigilanci\/farmakovigilancni-software\/platforma-tepsivo\/\">platformy Tepsivo<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; custom_padding_last_edited=&#8220;on|desktop&#8220; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#fafafa&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#fafafa 0%|#ffffff 100%&#8220; background_color_gradient_start=&#8220;#fafafa&#8220; background_color_gradient_end=&#8220;#ffffff&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;0px||||false|false&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;2px||39px||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;&#8220; top_divider_color=&#8220;#ffffff&#8220; top_divider_height=&#8220;89px&#8220; top_divider_flip=&#8220;horizontal&#8220; bottom_divider_color=&#8220;#ffffff&#8220; bottom_divider_height=&#8220;53px&#8220; bottom_divider_flip=&#8220;horizontal&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;2&#8243; _builder_version=&#8220;4.16&#8243; background_enable_color=&#8220;off&#8220; width_tablet=&#8220;&#8220; width_phone=&#8220;100%&#8220; width_last_edited=&#8220;on|phone&#8220; max_width=&#8220;876px&#8220; custom_margin=&#8220;53px||||false|false&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;40px||21px||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;1px||1px||false|false&#8220; border_radii=&#8220;off||||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;1.6em&#8220; ul_font=&#8220;||||||||&#8220; ol_font=&#8220;||||||||&#8220; header_font=&#8220;||||||||&#8220; header_2_font=&#8220;Merriweather|700|||||||&#8220; header_2_font_size=&#8220;36px&#8220; header_2_line_height=&#8220;1.6em&#8220; header_3_font=&#8220;Merriweather|700|||||||&#8220; header_3_text_color=&#8220;#ffc47c&#8220; header_3_font_size=&#8220;18px&#8220; header_3_line_height=&#8220;1.8em&#8220; header_4_font=&#8220;||||||||&#8220; header_5_font=&#8220;||||||||&#8220; header_6_font=&#8220;||||||||&#8220; text_orientation=&#8220;center&#8220; max_width=&#8220;80%&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;1px|||||&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;|0px||0px|false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;|0px||0px|false|false&#8220; header_2_font_size_tablet=&#8220;&#8220; header_2_font_size_phone=&#8220;20px&#8220; header_2_font_size_last_edited=&#8220;on|phone&#8220; header_3_font_size_tablet=&#8220;&#8220; header_3_font_size_phone=&#8220;14px&#8220; header_3_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"font-weight: 400;\">Ozv\u011bte se n\u00e1m a my v\u00e1m uk\u00e1\u017eeme, jak vyu\u017e\u00edt na\u0161i \u0161ablonu PSMF, kter\u00e1 p\u0159esn\u011b odpov\u00edd\u00e1 po\u017eadovan\u00fdm sm\u011brnic\u00edm. 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Mus&iacute;te ho vytvo&#345;it a pravideln&#283; aktualizovat, abyste p&#345;i inspekci mohli dolo&#382;it, jak v&aacute;&scaron; syst&eacute;m farmakovigilance funguje.Jak ho pro v&aacute;s vytvo&#345;&iacute;me? Sestaven&iacute; PSMF nen&iacute; &#382;&aacute;dn&aacute; v&#283;da, to podstatn&eacute; je v jeho obsahu. Pokud pot&#345;ebujete nastavit nov&yacute; syst&eacute;m farmakovigilance, ozv&#283;te se n&aacute;m. D&iacute;ky [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"_yoast_wpseo_title":"Z\u00e1kladn\u00ed soubor farmakovigilan\u010dn\u00edho syst\u00e9mu (PSMF) | Rychl\u00e9 nastaven\u00ed pomoc\u00ed Tepsivo","_yoast_wpseo_metadesc":"Nastavte si nov\u00fd farmakovigilan\u010dn\u00ed syst\u00e9m Tepsivo a v\u00e1\u0161 PSMF bude automaticky p\u0159ipraven. 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