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POUR Repository Webinar on API: Q&A on Preparedness for Usage 21 May 15 Chairs: Boris Kampmeijer (MEB) and Estonia Korakianiti (EMA) An agency of the European Union Agenda # Topic Resp Time Chairs
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Who needs psur repository webinar on:
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Pharmaceutical professionals involved in pharmacovigilance and drug safety reporting.
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Regulatory professionals responsible for preparing and submitting Periodic Safety Update Reports (PSURs) to regulatory authorities.
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What is psur repository webinar on?
The PSUR repository webinar is on the submission process for Periodic Safety Update Reports.
Who is required to file psur repository webinar on?
Marketing Authorization Holders (MAHs) are required to file PSURs in the repository.
How to fill out psur repository webinar on?
PSURs can be filled out by following the specific guidance provided during the webinar.
What is the purpose of psur repository webinar on?
The purpose of the PSUR repository webinar is to ensure accurate and timely submission of safety reports.
What information must be reported on psur repository webinar on?
PSURs must include information on the safety profile of the medicinal product.
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