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POUR Submissions in Single Assessment via EMA Gateway Web client An agency of the European Union Presenters of the Day, from EMA Natasha Brown (ICT/Organizer) Jaspreet Singh (ICT/Presenter) Panel:
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What is psur submissions in single?
Single PSUR submission is a process where regulatory agencies require pharmaceutical companies to submit a Periodic Safety Update Report (PSUR) to provide updated safety information on a medicinal product.
Who is required to file psur submissions in single?
Pharmaceutical companies who have received marketing authorization for a medicinal product are required to file PSUR submissions in single.
How to fill out psur submissions in single?
PSUR submissions in single usually require detailed safety information, including adverse event reports, patient population data, and safety analyses. The specific requirements and format for filling out the submissions can vary depending on the regulatory agency.
What is the purpose of psur submissions in single?
The purpose of PSUR submissions in single is to ensure that regulatory agencies have up-to-date safety information on medicinal products. This allows them to continually evaluate the benefit-risk profile of the products and take any necessary regulatory actions.
What information must be reported on psur submissions in single?
On PSUR submissions in single, pharmaceutical companies must report adverse event data, including serious adverse events, patient exposure data, and any significant safety findings. Additionally, they may also need to include information on changes in product labeling or any new safety concerns.
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