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31. Mai 2024 · Provisions regarding the conduct of clinical trials are defined in clinical trials directive 2001/20/EC (good clinical practice—GCP), translated into concrete guidance in Eudralex volume 10—“Clinical trials guidelines.” Chapter I “Application and Application Form” demands, among other documentation, an IMP dossier.
31. Mai 2024 · EudraLex EU Legislation Guidelines to “The rules governing medicinal products in the European Union, Volume 4 – Guidelines for good manufacturing practices for medicinal products for human and veterinary use, Part IV – GMP requirements for Advanced Therapy Medicinal Products, European Commission, 22.11.2017. Google Scholar
Vor 8 Stunden · Clinical Trial Regulatory Requirements: 2-Day Online Training Course (September 16-17, 2024) - Highlights the Most Important Key Requirements, Changes, and Their Impact on Trials. Dublin, May 30 ...
Vor 17 Stunden · Dublin, May 30, 2024 (GLOBE NEWSWIRE) -- The "Clinical Trial Regulatory Requirements Training Course" conference has been added to ResearchAndMarkets.com's offering. Are you up to date with the regulatory requirements for clinical research in the EU and key requirements in the US? Do you understand the impact of the new requirements of the EU Clinical Trials Regulation? This course will take ...
