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GMP News

What are the GMP Requirements for Consultants?

In FDA warning letters, the FDA sometimes advises the employment of a consultant in order to remedy the deficiencies addressed. But what are the requirements regarding such consultants from a GMP perspective?

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ICH published updated Q8/Q9/Q10 Questions & Answers Document

The ICH has published an updated Q8/Q9/Q10 Q&A document to further clarify the implementation of the guidelines.

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Swissmedic Position Paper on Clinical Trials

The Swissmedic and the Swissethics jointly published a position paper on clinical trials with medicinal products examined for the first time in humans. The paper describes special aspects to be considered during the planning and conduct of such clinical trials by the sponsors and participating clinical trial centres.

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