. Qualified Person Forum 2017 .

Pre-Conference Sessions

29 November 2017

Full Day Pre-Conference Session

Specific Requirements for IMPs
Facilitated by: Justin Barry / Mark Birse / Susanne Ding / Gerald Finken / Niina Taylor / Brenda Van Assche / Philippe Van der Hofstadt (other speakers invited)

  • New legislation impacting IMP QPs
  • GMP inspection findings on IMPs
  • Just-in-time labelling/ on demand packaging and labelling
  • Interactive sessions and case studies – decision making of IMP QPs
  • Q&A sessions
  • ATMP Task Force (IMP focus): introduction and current status

1/2 Day Pre-Conference Session

The QP in special Areas: ATMPs, Radiopharmaceuticals, Blood and Blood Products
Facilitated by: Ørjan Apeland / Gabriella Cipra / Georg Göstl / Sue Mann / Christina Meissner

New classes of medicines such as ATMPs, Blood and Tissue Products or Radiopharmaceuticals are creating special challenges for the QPs certifying these products. This session aims to provide good insight and experienced views, address and discuss challenges and see what the participating delegates can learn from each other.

1/2 Day Pre-Conference Session

The QP in Contact with the Inspectorates and Authorities
Facilitated by: Rainer Gnibl / Ulrich Kissel / Katja Kotter

  • GMP-Inspection: how much QP involvement is needed?
  • Typical questions for QPs in inspections
  • QP quality oversight: Focus on third country products
  • Delegation of tasks and responsibilities: requirements, possibilities and boundaries
  • How the QP can demonstrate the on-going reliance on the QM-System