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Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more

The new Clinical Trials Regulation – what you need to know now - Episode 4: Protection of vulnerable groups.

With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode : Protection of vulnerable groups This part of the series is about the protection of the...more

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