OTC Medicines

RWD & RWE in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences Working Group XIII 

A report summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII on Real-World Data (RWD) and Real-World Evidence (RWE) has been published in the Pharmacoepidemiology and Drug Safety (PDS) journal.

RWD & RWE in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences Working Group XIII 

EMA Consultation – Reflection Paper on Regulatory Testing Requirements for Medicinal Products & Opportunities for Implementation of 3Rs 

The draft EMA reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs (replacement, reduction, refinement) has been published for consultation. In addition, the 3Rs Working Party is holding a plenary meeting to showcase the Agency's commitment to ensuring the implementation of 3Rs principles in the development and evaluation of medicinal products.

EMA Consultation – Reflection Paper on Regulatory Testing Requirements for Medicinal Products & Opportunities for Implementation of 3Rs 
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