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Publications & News
Browse our publications and read our blog posts on regulatory news and trends.
Pharmaceutical Legislation of the European Union, Japan and the United States of America – An Overview, Updated and Expanded Second Edition
Written by experts, this book helps you understand how the US, Japan and the EU regulate pharmaceuticals.
SPOR” – does that remind you of your Latin lessons and “SPQR”? Notice the difference – the little hook that turns the ‘O’ into a ‘Q’ ….
Publications » News EU: GMP for IMPs in View of the Revision of the EU Clinical Trial Provisions Separate legal provision for ‘GMP for IMPs’ and for ‘GMP for medicinal products’ Separate legal provision for ‘GMP for IMPs’ and for ‘GMP for medicinal products’ The legal framework for conducting clinical