Qualified Person Forum

The Pre-Conferences - 11 October 2023

Full Day Pre-Conference Session

Specific Requirements for IMPs
9.00-18.00 h (CEST)

Facilitated by:
Susanne Ding | Katrien Himpens | Patryk Jegorow | Anna Maria Kurzreiter | Marianne Lunzer | Niina Taylor (other speakers invited)

  • Legislation impacting IMP QPs
  • Clinical Trial Regulation – experience so far
  • Clinical Trial Information System (CTIS) – what IMP QPs need to know
  • ATMP GMP Part IV – challenges for IMP QPs
  • Application of Quality Risk Management
    Interactive Case Study
  • Q&A sessions

Please see the registration options to register for the Pre-Conference Session or the Qualified Person Forum & the Pre-Conference Session.

1/2 Day Pre-Conference Session

Quality Culture
13.30-18.00 h (CEST)

Facilitated by:
Energy Kristina Hansen

  • Leadership roles on Q-Culture
  • Steps to establishing an excellence led culture
  • Q-Culture framework in the organisation

1/2 Day Pre-Conference Session

New QPs meet experienced QPs
13.30-18.00 h (CEST)

Facilitated by:
Georg Göstl | Andreas Kraßnigg | Sue Mann

A tailor-made session for new and aspiring QPs with round-table discussions and lots of interaction. Discuss your questions and worries with experienced QPs and a GMP Inspector.