Event Details

This course will provide an overview of Advanced Therapy Medicinal Products (ATMPs) and the regulatory framework for clinical trials. Participants will gain an understanding of the medicinal product life cycle, including pre-clinical and clinical development, as well as post-authorization requirements. The course will also cover the latest guidance and regulations from regulatory bodies such as EMA and FDA. The focus will be on gene and cell therapies, as well as tissue-engineered products.