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 / Edel Shortt / Andreas Schwinn

  • 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: Fabio Cirillo / 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
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