Drug Development and Regulations: Europe

This lecture covers the drug development process in Europe, from discovery to marketing authorization. It explains the phases of clinical trials, the European regulatory framework, the new Clinical Trials Regulation, and the Clinical Trials Information System. The transition from the Clinical Trial Directive to the Clinical Trials Regulation is detailed, along with the life cycle of a clinical trial application. The importance of transparency in clinical trials, the Marketing Authorization Application dossier, and the different Marketing Authorization Procedures and types in Europe are also discussed.