Drug Safety Training – Aggregate reporting
Periodic Reporting is the preparation and submission of safety information(Adverse events, lack of efficacy, accidental exposure, medication error, withdrawal effects, product quality complaints, off-label use etc) about a medicinal product on a periodic or timely basis e.g every year or every 3 months or every 6 months.
These reports are also known as aggregate reports or cumulative reports since these reports present a compilation of safety data over a prolonged period of time as opposed to single case reporting which involves only individual AE reports (ICSRs). Periodic reports play an important role in risk-benefit evaluation of a drug and are required to be submitted to various regulatory agencies to comply with regulatory requirements. They provide a broader view of the safety profile of a drug.
Major types of Periodic Reports are:
DSUR — Development Safety Update Report
Its a periodic report for drugs under development(including marketed drugs that are under further study). It is submitted on annual basis. It replaces the current IND Annual Report (AR) in US and Annual Safety Report(ASR) in EU.
PSUR — Periodic Safety Update Report
PADER — Periodic Adverse Drug Experience Report
PBRER: Periodic Benefit Risk Evaluation Report
These are periodic report for Drugs that are approved and are commercially being used.
Differences between PSUR and PADER are outlined below:
In 2012, the guidelines for PSUR were revised with the recognition of the fact that assessment of the risk of a medicinal product is more meaningful when evaluated in context of its benefits. Hence the report format of PSUR was changed to PBRER. The PSUR/PBRER is an aggregate safety report that is accepted worldwide including the European Union, Japan, and Canada. Though FDA US recommends periodic submission of a PADER but Marketing Authorization Holder(The company that is authorized to sell the drug) can submit PSUR/PBRER along with NDA listings (also called US Supplement/FDA PSUR) in place of PADER after obtaining a waiver.
Some differences between PSUR and PBRER are:
Our Drug Safety training program combines theoretical concepts with practical application and hands-on safety database case processing. After successful Drug Safety training certification, we provide 100% Job placement assistance through our industry collaborations.
To learn more about Aggregate reporting in our Certification program in Advanced Drug Safety and Pharmacovigilance, please visit https://medipharmsolutions.com/drug-safety-associate-and-pharmacovigilance-training/
Or call us at 848-230-0240.
