Safety Observer

Request complete sample report for free 🙌
March 2024

Safety Observer 209

ICH has published for the E2D(R1) draft Guideline on Post-Approval Safety Data.

Released 04-Mar-2024
Pages 36
Subscribe Highlights

Report 209 — Highlights

ICH draft E2D(R1) Guideline

ICH has published for consultation the E2D(R1) draft Guideline, which covers: “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports”.

FDA Draft Guidance on DMCs

The FDA is calling for comments on a new draft guidance entitled: “Use of Data Monitoring Committees in Clinical Trials”, which is intended to replace the guidance from March 2006.

FDA Draft Guidance on Informed Consent

The FDA has also published for comments a new draft guidance entitled: “Key Information and Facilitating Understanding in Informed Consent”.

EU : New RWD Catalogues

The EMA has launched the two EMA-HMA catalogues of RWD (Real-World Data) sources and RWD studies, which replace the ENCePP Resources Database and EU PAS Register.

SO Service Update

The first “mega” client account (nearly 500 users) was onboarded to the new Reading Platform in February and the total number of user accounts is now greater than 900.

Sign up for alerts

Receive alerts and news on pharmacovigilance regulatory requirements every month.

Register today!

Safety Observer

EUR (€)
My account


3-Month Plan

This Plan includes three consecutive reports starting with the next release. The perfect solution to test the value of our service.

Starts at 180 

1-Year Plan

This Plan includes eleven consecutive reports starting with the next release. Includes a double issue for July/August.

Starts at 600 

Stay in the loop

Join over 1,000 Pharmacovigilance professionals and receive our Free Content straight to your mailbox !