What is included in PSUR?
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorisation.
What is PSUR and RMP?
· Focus of PSUR is retrospective review of integrated risk benefit analysis whereas RMP is proactive prospective plan to deal with known risks and identify and further characterize little known risks.
What is the purpose of PSUR?
PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.
How do you write a PSUR?
Top 10 Tips for Writing PSURs and PMS Reports
- Keep the goal top of mind.
- Align your report with your PMS plan.
- Identify and gather source data.
- Meet the minimum data requirements outlined in the regulation.
- Perform data analysis.
- Reference previous PSURs/PMS reports.
- Review literature on a regular basis.
What is Regulatory Affairs PSUR?
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document which provides information related to the risk-benefit balance of a drug product post its authorization.
Does FDA require DSUR?
Annual Reports or DSURs to the FDA Finally, FDA has indicated that it will accept DSURs instead of IND Annual Reports (76 Federal Register 52667 (23Aug2011) as long as they have all the requirements of the US Annual Report in the region specific appendices of the DSUR.
What is the difference between Pader and PSUR?
The EU requires pharmaceutical companies to file a periodical safety update report (PSUR), which is also used in many other countries. In the U.S., the FDA requires organizations to file a periodic adverse drug experiences report (PADER).
What is Pbrer in pharmacovigilance?
A Periodic Benefit Risk Evaluation Report (PBRER) is a format of safety report described by the ICH-E2C(R2) guideline which is used as a basis for the EU Periodic Safety Update Report (PSUR).
Is PSUR and Pbrer same?
Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER) Periodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug.
What is the result of the assessment of a PSUR?
The assessment of a PSUR may result in a recommendation to update the content of the RMP through a subsequent variation.
What is Article 35 of the Commission Implementing Regulation?
Article 35 of the Commission Implementing Regulation describes the structure of PSURs. (GVP) provides guidance on the preparation, submission and assessment of PSURs. This format is a legal requirement for both nationally authorised products and centrally authorised products.
What is the legal basis for psurs?
· Legal basis for PSURs: Regulation (EC) No 726/2004, Directive 2001/83/EC and in the Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC.
Can I use the PSUR repository for the initial PSUR submission?
The regulatory activity ‘PSUR’ can only be used for the ‘initial’ PSUR submission due to the built-in business rules linking to the submission deadline. Please refer to the e-submission webpage and the PSUR Repository MAH user guide for more information on the creation of the delivery file.