Safety Observer 209

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FDA Draft Guidance on DMCs

The FDA is calling for comments on a new draft guidance entitled: “Use of Data Monitoring Committees in Clinical Trials”, which is intended to replace the guidance from March 2006.

FDA Draft Guidance on Informed Consent

The FDA has also published for comments a new draft guidance entitled: “Key Information and Facilitating Understanding in Informed Consent”.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