ATMP Basics for Clinical Researchers (Classroom 15 Oct 2020)

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.

TRIUM reference: T0357

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
Lieve De Wolf
Lieve De Wolf has obtained her master of science degree at the university of Ghent in industrial pharmacy. After her studies Lieve performed her traineeship and registered as QP. Within the industry Lieve worked on r validation project (e.g. isolators), performed quality reviews of validation dossiers. Lieve is a member of the ATMP core team at Quality by Design NV. Currently she is implementing a GMP downstream purification process train at eTheRNA.