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On the ECA Academy website you have all the important information for your daily work in the GMP/GDP environment directly at hand: current news, suitable online training, eLearning offers, conferences, seminars and courses, a comprehensive guideline database and many other services. Should you not find what you need, just contact us by phone at +49 (0)6221 / 84 44 0 or send an e-mail to info@gmp-compliance.org.

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GMP News

Proposals by the Notified Bodies to amend the Medical Devices Regulation

The Team Notified Bodies has published proposals for revising the regulatory framework for medical devices and in vitro diagnostics (IVDs). What do the Notified Bodies have in mind?

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Artificial Intelligence in Medical Devices - The MHRA's Perspective

In 2024, the UK's MHRA, together with the US FDA and Health Canada, published 10 guiding principles on "Good Machine Learning Practice" (GMLP). These have now been expanded.

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FDA Updates how it Evaluates and Inspects Human Drug Facilities

Behind the FDA's new ConOps 2.0 is a sharper division of labor between CDER and OII, and new tools that make remote assessments and foreign inspection reports count toward facility decisions. Read what manufacturers need to know now.

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