Advanced Therapy Medicinal Products (ATMPs) are a fast-growing field of innovative therapies. Clinical development of ATMPs has specific challenges and requires different procedures for clinical trials compared to traditional medicinal products. This half-day course is intended to provide clinical researchers an overview of the different types of ATMPs, the challenges of ATMPs in clinical research and the regulatory framework for ATMPs in Europe.
By the end of this TRIUM Training you should be able to:
- Describe the different types of ATMPs and explain how they differ from traditional therapeutic approaches
- Explain the impact of the complexity of ATMPs on the development & implementation of a clinical investigation
- Consult the regulations and guidelines applicable for ATMPs
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.