Get the free PSUR Repository user guide for NCA users - eSubmission - Europa bb
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08 June 2016 EMA/52448/2015 v6.0 User Guidance for National Competent Authorities for POUR Repository 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 8427 Facsimile
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How to fill out psur repository user guide
How to fill out psur repository user guide:
01
Start by gathering all the necessary information and documents related to the PSUR (Periodic Safety Update Report) that you want to submit to the repository.
02
Access the PSUR repository system and log in using your designated credentials.
03
Navigate to the section or category specifically designed for submitting PSURs.
04
Review the guidelines and instructions provided by the repository to ensure you understand the requirements for filling out the user guide.
05
Begin by entering the basic details of the PSUR, such as the report title, submission date, and the period covered by the report.
06
Follow the step-by-step instructions to provide information on the drug or medical product being reported, including its name, active ingredients, dosage forms, and strengths.
07
Provide a summary of the safety information and findings from the PSUR, including any adverse events or side effects observed during the reporting period.
08
Include a detailed analysis of the collected safety data, highlighting any trends, patterns, or changes compared to previous reports.
09
Provide conclusions and recommendations based on the safety assessment conducted in the PSUR.
10
Finally, review the completed user guide to ensure all the required information has been accurately and comprehensively filled out before submitting it to the repository.
Who needs psur repository user guide?
01
Pharmaceutical companies or manufacturers who are required to submit Periodic Safety Update Reports (PSURs) for their drugs or medical products.
02
Regulators and authorities responsible for monitoring the safety and efficacy of pharmaceutical products in a specific jurisdiction.
03
Healthcare professionals and researchers who may need access to aggregated safety data for a particular drug or medical product to make informed decisions regarding its usage.
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What is psur repository user guide?
The psur repository user guide is a document that provides instructions on how to submit Periodic Safety Update Reports (PSURs) to the regulatory authorities.
Who is required to file psur repository user guide?
Marketing authorization holders are required to file the psur repository user guide.
How to fill out psur repository user guide?
The psur repository user guide can be filled out electronically through the designated online portal provided by the regulatory authorities.
What is the purpose of psur repository user guide?
The purpose of the psur repository user guide is to ensure that PSURs are submitted in a standardized format and in a timely manner.
What information must be reported on psur repository user guide?
The psur repository user guide must include information on the safety and efficacy of the drug, any adverse events reported, and any changes to the risk mitigation measures.
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