Summary
This 2-day course will provide you with a comprehensive overview of the regulatory, quality and GxP requirements to consider when developing ATMPs. You will receive a regulatory update, explore regulatory pathways and procedure types as well as recommendations for common hurdles.
Learning Objectives
- Regulatory expectations for ATMP products
- Overcome development and marketing authorisation challenges
- Practical implementation of regulatory expectations & a comprehensive regulatory update
- Understand the GxP requirements for ATMPs
- Take advantage of the available regulatory advice
- Understand different procedure types
Key Topics
- Regulatory Framework (EMA, FDA, National)
- ATMP Procedures (Types; Centralised, National)
- The Medicinal Product Life Cycle (ATMP)
- GxP Requirements
- Marketing Authorisation
- Post- Authorisation/ Pharmacovigilance
Who should attend?
This course is suitable for all those involved in:
- Regulatory Affairs
- Project Managers
- Clinical Research/ Development/ Trials
- Drug Development
- Quality & Compliance
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Dr. Rensing studied biology and medicine at Tübingen, Heidelberg and Amherst, USA. During his clinical career he contributed to more than 40 clinical trials in all phases. He has worked in hospital management, the pharmaceutical industry as well as at The Paul-Ehrlich-Institute (PEI) as a clinical assessor.
Development of ATMPs: The Medicinal Product Life Cycle & Regulation
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