The European Medicines Agency (EMA) has proposed expanding Annex 15 of the EU EudraLex to make it mandatory for all chemical and biological active substance (AS) manufacturers in a concept paper. The ...
A new harmonised template (Version 2.0) for participant recruitment and informed consent is now available for all clinical trials conducted in ...
While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at ...
The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI ...
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