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[Dear Sir or Madam,

With this newsletter we would like to inform you about the following current GMP trends.

Your
ECA Team

The U.S. Food and Drug Administration (FDA) recently published a Questions and Answers (Q&A) guidance on the use of electronic informed consent in clinical investigation. Read more about the FDA Guidance "Use of Electronic Informed Consent Questions and Answers".

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Get an overview on state of the art know-how of the different important and central topics in this exclusive Capsule Technology seminar in Heidelberg, Germany, from  8-9 March 2017. Pharmacists and suppliers will share their expert knowledge in presentations for example on filling of liquids, containment as well as on the latest capsule filling technologies. Additionally, you will be trained on selected aspects of trouble shooting as well as on scale-up and Qualification/Validation. Please see the programme for further information.

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The ICH recently published a reflection paper on “GCP Renovation” regarding the modernization of ICH E8 (General Considerations for Clinical Trials) and the subsequent renovation of ICH E6 (Guideline for Good Clinical Practice). Read more about ICH´s Reflection Paper on the potential renovation of the ICH guidelines related to clinical trials.

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Forced degradations are the basis for development of analytical methods and drug formulations, for understanding the degradation mechanisms and for predicting the stability behavior of active ingredients and drug products. During the course in Berlin from 4-5 April 2017 you will get an overview of the basic chemistry of the common degradation reactions. Additionally, this course will teach you how they are practiced in the pharmaceutical industry, and how you can carry them out on your own. Please see the programme for further information.

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Critical violations in view of the inspected studies as well as serious deficiencies in the quality management system of two Indian study sites were found during GCP inspections. Read more on the findings of the GCP inspections conducted at two Indian Sites.

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Specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and IMP Manufacturing from 10-12 May 2017 in Prague. Please see the programme for further information.

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• EMA's Concept Paper on Non-Clinical Documentation for Herbal Medicinal Products published
• ICH M9: Biopharmaceutics Classification System-based Biowaivers

For further recent news please go here.

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Here you will find an updated overview of forthcoming education courses and conferences.

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Yours sincerely,

The European Compliance Academy

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