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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

Utility of Comparative Efficacy Studies in Biosimilar Development

How and to what extent comparative efficacy studies are useful in the development of biosimilars has been discussed many times. The ICH has now published a concept paper on this topic with plans to publish draft guidelines in 18 months.

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Insurance Review in Phase 1 Clinical Trials

The new UK regulations for clinical trials will take effect on 28 April 2026. For clinical trials of investigational medicinal products (IMPs), the research ethics committee (REC) application must include any document providing evidence of insurance to cover the sponsor's or investigator's liability. What are the GCP responsibilities for insurance review?

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EMA Publishes Comments on ICH E21

The EMA published the comments on the draft ICH Guideline E21 on the inclusion of pregnant and breastfeeding individuals in clinical trials in a consolidated tabular overview. The comments received will now be discussed and implemented by the expert group.

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