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October 2022

Safety Observer 193

The FDA has published the final guidance on RWD and RWE Documents Submissions for Drugs and Biological Products.

Released 05-Oct-2022
Pages 32
Highlights

Report 193 — Highlights

FDA: RWD/RWE submission

The FDA has published the final guidance entitled “Submitting Documents Using Real-World Data (RWD) and Real-World Evidence (RWE) to FDA for Drugs and Biological Products”.

EMA Guide on RWD sources

The EMA has published for consultation a Good Practice Guide for the use of the catalogue of data sources that will replace the currently available ENCePP catalogue.

Tanzania QPPV

The Tanzania Medicines and Medical Devices Authority (TMDA) has published instructions for the required notification regarding the Qualified Person for PharmacoVigilance (QPPV).

UMC explains IDMP

In the latest “Drug Safety Matters” podcast episode, the Uppsala Monitoring Centre (UMC) explores the advantages and challenges of Identification of Medicinal Products (IDMP) standards.

CIOMS PV Glossary

CIOMS has published Version 2.0 of its Cumulative Glossary with a focus on Pharmacovigilance.

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