.
Pre-Conference Sessions
01 December 2021
Full Day-Pre-Conference Session (1 December 2021)
Specific Requirements for IMPs
Facilitated by: Tara Cox / Susanne Ding / Rainer Gnibl / Patryk Jegorow / Sue Mann / Niina Taylor / Catherinr Neary /
Rafael Santis / Brenda Van Assche
- New legislation impacting IMP QPs
- Experiences with Brexit
- Are you ready for the new IMP GMP regulation?
- Inspector’s view on IMP topics
- Investigational ATMPs
- Phase appropriate GMP
- Interactive sessions and case studies – decision making of IMP QPs
- Q&A sessions
1/2 Day Pre-Conference Session (1 December 2021)
Human Error
Facilitated by: Sue Mann / Energy Kristina Hansen
- What is behind “Human Error”?
- Considering human behaviours
- Is Human error avoidable?
- Tips for reducing human errors
1/2 Day Pre-Conference Session (1 December 2021)
How to certify Drug-Device Combinations
Facilitated by: Rainer Gallitzendörfer / Peer Schmidt
- What the QP needs to know about the new Medical Devices regulations
- Responsibilities of the QP when certifying DDCs (start and end)
- How to prove compliance with medical device regulations and other requirements
- Expectations of the Agencies
- Interface to and co-operation with Notifi ed Body
- Examples and experience made