ATMP Basics for Clinical Researchers

Description
Operational

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.

Learning objectives

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
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Gijs Klarenbeek
Gijs Klarenbeek has obtained his MD degree at the university of Leuven, Belgium and was trained as a surgeon in the University Hospital of Leuven. Within the industry, Gijs has experience since 2005 in different medical advisory and management roles. With a background in both pharmaceutical and medical devices context, Gijs has expertise in the cardiovascular and many other therapeutic areas. His medical background and strategic mindset are a significant added value to the team and our clients.