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Medical Writing of Periodic Safety Update Reports Virtual Live Training Course 2628 April 2022 09:0013:00 CESTOVERVIEW Quality of Periodic Safety Update Reports (Pours)/Periodic Benefit Risk Evaluation
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How to fill out periodic safety update reports
How to fill out periodic safety update reports
01
Begin by collecting all relevant safety data from clinical trials, post-marketing studies, and other sources.
02
Analyze the safety data to identify possible trends or signals of potential safety issues.
03
Summarize the safety data in a clear and concise manner, including any changes in the risk-benefit profile of the product.
04
Include any regulatory updates or concerns related to the product.
05
Submit the completed periodic safety update report to the appropriate regulatory authorities within the specified timeline.
Who needs periodic safety update reports?
01
Pharmaceutical companies and Marketing Authorization Holders (MAHs) are required to submit periodic safety update reports to regulatory authorities as part of post-approval monitoring and surveillance.
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What is periodic safety update reports?
Periodic Safety Update Reports (PSURs) are reports that provide a comprehensive analysis of the risk-benefit balance of a medicinal product.
Who is required to file periodic safety update reports?
Marketing authorization holders are required to file periodic safety update reports for their medicinal products.
How to fill out periodic safety update reports?
Periodic safety update reports should be filled out following the guidelines provided by regulatory authorities such as the EMA or FDA.
What is the purpose of periodic safety update reports?
The purpose of periodic safety update reports is to monitor and evaluate the safety profile of a medicinal product over time.
What information must be reported on periodic safety update reports?
Periodic safety update reports should include information on suspected adverse reactions, patient exposure, risk minimization measures, and any other relevant safety data.
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