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EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs

The European Medicines Agency (EMA) yesterday (26 April, 2024) released an updated guidance on the "Anonymisation of protected personal...

EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)

Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment...

USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages

The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...