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January 2024

Safety Observer 207

The FDA has published new guidance documents on RWD and RWE.

Released 08-Jan-2024
Pages 35
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Report 207 ā€” Highlights

FDA Guidance on RWD

The FDA has published new final guidance documents to help advance the use of RWD (Real-World Data) and RWE (Real-World Evidence) in the lifecycle of medicines.

FDA: Vaccine ICSRs

The FDA has released a new version of the Specifications for the electronic submission of ICSRs for Vaccines.

EU CTR guidance

A new version of the Q&As on the EU CTR (Clinical Trials Regulation (EU) NĀ°536/2014) has been published, which brings clarifications on applicable Safety Reporting requirements.

Learning events

The FDA, the MHRA and Health Canada will hold a joint GCP & PV Compliance Workshop from 13 to 15-Feb-2024, while a new MHRA GPvP Symposium will take place on 28-Feb-2024.

SO Service Update

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