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Pharma Expertise Consulting supports you from Periodic Safety Update Report (PSUR) <\/strong>preparation\u00a0to the establishment of complete pharmacovigilance systems<\/strong>. Drug approvals require companies to have a pharmacovigilance system in place (Summary Pharmacovigilance System Master File according to Directive 2010\/84\/EU<\/strong>). For this purpose, risk management plans and associated Standard Operating Procedures (SOPs) must be established.<\/p>\n We confirm the safety of approved medicinal products. Depending on your needs, we can take on individual tasks such as the assessment of adverse drug reactions (ADRs)<\/strong> \/ serious adverse events (SAEs)<\/strong> and\/or compliance with reporting obligations\u2013or we can create your entire pharmacovigilance system from scratch.<\/p>\n On behalf of your company, we manage the electronic reporting of suspected cases to EudraVigilance<\/strong> <\/a>as well as the monitoring of the database (signal management) of adverse drug reactions (ADRs)<\/strong>. Serious suspected cases must be reported to the database operated by the European Medicines Agency (<\/strong><\/a>EMA)\u00a0<\/a><\/strong> within 15 days (non-serious within 90 days).<\/p>\n As a pharmaceutical manufacturer<\/strong>, you need a step-by-step plan officer (Section 63a of the German Medicines Act<\/strong>) or a Qualified Person for Pharmacovigilance (QPPV)<\/strong> to set up and manage the pharmacovigilance system. This pharmacovigilance officer must be available around the clock, including binding deputy arrangements in case of vacation, illness, etc.<\/p>\n We support you in establishing the pharmacovigilance system as well as in filling the position of the step-by-step plan officer including deputy regulations.<\/p>\n We are happy to support you. Just contact us!<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”\/en\/contact” button_text=”Make a consultation appointment” _builder_version=”4.17.3″ _module_preset=”default” custom_button=”on” button_text_size=”13px” button_text_color=”#FFFFFF” button_bg_color=”#16918f” button_border_width=”4px” button_border_color=”#16918f” button_border_radius=”0px” button_font=”Manrope|||on|||||” button_icon=”$||divi||400″ button_icon_color=”#FFFFFF” background_layout=”dark” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Pharmacovigilance (drug saftey) Our drug service in the area of pharmacovigilancePharma Expertise Consulting supports you from Periodic Safety Update Report (PSUR) preparation\u00a0to the establishment of complete pharmacovigilance systems. Drug approvals require companies to have a pharmacovigilance system in place (Summary Pharmacovigilance System Master File according to Directive 2010\/84\/EU). For this purpose, risk management plans and […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":" [et_pb_section fb_built=\"1\" fullwidth=\"on\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_fullwidth_image src=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-arzneimittel-min.jpg\" alt=\"Pharma & Arzneimittel\" title_text=\"Arzneimittel\" _builder_version=\"4.11.4\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=\"1\" _builder_version=\"4.11.1\" _module_preset=\"default\" custom_margin=\"||||false|false\" custom_padding=\"||||false|false\" global_colors_info=\"{}\"][et_pb_row _builder_version=\"4.10.7\" custom_margin=\"||0px||false|false\" custom_padding=\"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=\"4.14.2\" text_font=\"Manrope||||||||\" text_line_height=\"2em\" header_font=\"Manrope|600|||||||\" header_text_color=\"#20292f\" header_font_size=\"26px\" header_line_height=\"1.3em\" header_2_font=\"Manrope|600||on|||||\" header_2_text_color=\"#193b7a\" header_2_font_size=\"14px\" header_2_letter_spacing=\"1px\" header_2_line_height=\"1.2em\" header_3_font=\"Rubik|500|||||||\" header_3_font_size=\"38px\" header_3_line_height=\"1.4em\" custom_margin=\"0px||0px||false|false\" header_2_font_size_tablet=\"42px\" header_2_font_size_phone=\"32px\" header_2_font_size_last_edited=\"off|desktop\" header_3_font_size_tablet=\"28px\" header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\"]<\/p> [\/et_pb_text][et_pb_text _builder_version=\"4.14.2\" text_font=\"Manrope||||||||\" text_text_color=\"#6d7c90\" header_font=\"Manrope|600|||||||\" header_line_height=\"1.4em\" header_2_font=\"Rubik|500||on|||||\" header_2_text_color=\"#193b7a\" header_2_font_size=\"14px\" header_2_letter_spacing=\"1px\" header_2_line_height=\"1.5em\" header_3_font=\"Rubik|500|||||||\" header_3_font_size=\"38px\" header_3_line_height=\"1.4em\" custom_margin=\"0px||0px||false|false\" hover_enabled=\"0\" header_2_font_size_tablet=\"42px\" header_2_font_size_phone=\"32px\" header_2_font_size_last_edited=\"off|desktop\" header_3_font_size_tablet=\"28px\" header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\" sticky_enabled=\"0\"]<\/p> Pharma Expertise Consulting unterst\u00fctzt Sie von der PSUR-Erstellung (Periodic Safety Update Report)<\/strong>\u00a0bis hin zum Aufbau vollst\u00e4ndiger Pharmakovigilanz-Systeme<\/strong>. Arzneimittelzulassungen setzen voraus, dass Unternehmen ein Pharmakovigilanz-System haben (Summary Pharmacovigilance System Master File gem\u00e4\u00df Richtlinie 2010\/84\/EU<\/b>). Hierzu m\u00fcssen Risikomanagement-Pl\u00e4ne und dazugeh\u00f6rige Standard Operating Procedures (SOP) erstellt werden.<\/p> Wir best\u00e4tigen die Sicherheit zugelassener Arzneimittel. Je nach Bedarf \u00fcbernehmen wir dabei einzelne Aufgaben wie die Bewertung von Nebenwirkungen (Adverse Drug Reactions (ADR) \/ Serious Adverse Events (SAE))<\/b> und\/oder die Einhaltung der Meldeverpflichtungen<\/b> \u2013 oder wir erstellen gleich Ihr gesamtes Pharmakovigilanz-System<\/b>.<\/p> Im Auftrag \u00fcbernehmen wir die elektronische Meldung von Verdachtsf\u00e4llen an die EudraVigilance<\/a><\/b> sowie die \u00dcberwachung der Datenbank (Signal Management)<\/b> unerw\u00fcnschter Arzneimittelwirkungen (UAW)<\/b>.<\/b> Schwerwiegende Verdachtsf\u00e4lle m\u00fcssen innerhalb von 15 Tagen an die von der EMA (European Medicines Agency)<\/a> betriebene Datenbank <\/strong>gemeldet werden, nicht-schwerwiegende innerhalb von 90 Tagen.<\/p> Als pharmazeutischer Hersteller<\/strong> ben\u00f6tigen Sie f\u00fcr die Einrichtung<\/strong> und F\u00fchrung<\/strong> des Pharmakovigilanz-Systems<\/strong> einen Stufenplanbeauftragten (\u00a7 63a Arzneimittelgesetz)<\/strong> <\/b>beziehungsweise eine Qualified Person for Pharmacovigilance (QPPV)<\/strong>. Dieser Pharmakovigilanz-Verantwortliche muss rund um die Uhr verf\u00fcgbar sein, einschlie\u00dflich verbindlicher Stellvertreterregelungen bei Urlaub, Krankheit etc.<\/p> Wir begleiten Sie bei der Etablierung des Pharmakovigilanz-Systems sowie bei der Besetzung der Funktion des Stufenplanbeauftragten inklusive Vertretungsregelung.<\/p> Wir unterst\u00fctzen Sie gerne. Sprechen Sie uns einfach an!<\/strong><\/p> [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\"4.10.8\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"4.10.8\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_button button_url=\"\/kontakt\" button_text=\"Beratungstermin vereinbaren\" _builder_version=\"4.13.0\" _module_preset=\"default\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#FFFFFF\" button_bg_color=\"#16918f\" button_border_width=\"4px\" button_border_color=\"#16918f\" button_border_radius=\"0px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" background_layout=\"dark\" global_colors_info=\"{}\"][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-3450","page","type-page","status-publish","hentry"],"yoast_head":"\nPharmakovigilanz (Arzneimittelsicherheit)<\/h2>
Unser Arzneimittel-Service im Bereich Pharmakovigilanz<\/h1>