Safety Observer

June 2024

Safety Observer 212

New CIOMS XIII report: RWD & RWE in regulatory decision making.

Released 10-Jun-2024
Pages 32
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Report 212 — Highlights


CIOMS has published a new report entitled: “Real-world data (RWD) and real-world evidence (RWE) in regulatory decision making”.

ICH draft M14: RWD

ICH has published the M14 draft Guideline entitled “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines”.

FDA REMS Logic Model

The FDA has published a new draft guidance for comments, which provides a systematic, structured approach to the design, implementation, and evaluation of a REMS.

Zimbabwe: PV Guideline

The Medicines Control Authority of Zimbabwe (MCAZ) has published a revised version of its “Pharmacovigilance Guideline for Pharmaceutical Industry”.

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