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EU Clinical Trial Regulation

The EMA has published the CTIS go-live plan, which provides an overview of the remaining activities to prepare for the launch in January 2022. A new “CTIS Highlights” Newsletter calls for all future users to prepare for the changes to come and the Draft Q&As on the EU Clinical Trial Regulation have been updated.

EMA: Registry-based studies

The EMA has published the final guideline on registry-based studies, which covers all aspects related to the use of these studies as a source of real-world evidence (RWE) for regulatory decision-making.

ISO IDMP in the EU

The EMA has updated its procedural advice for users of the centralised procedure to highlight that the use of OMS data has now become mandatory in Central applications.

FDA: RWD submissions

The FDA has published a new draft guidance intended to support compliance when submitting study data derived from real-world data (RWD) sources.

FDA: FAERS

A new FAERS system (FDA Adverse Event Reporting System) will go live on 10-Nov-2021 and the FDA has warned that the content of some ICSR data elements may affect E2B transmissions.

Hot topics are taken from Safety Observer Lite Nov 2021

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