Safety Observer 207
The FDA has published new guidance documents on RWD and RWE.
Report 207 — 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) N°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
The new web-based Reading Platform has been launched and over 10 clients and 100 users now access their Safety Observer reports through this new tool.
