Qualified Person Forum

The Pre-Conferences - 27 November 2024

Full Day Pre-Conference Session

Specific Requirements for IMPs
9.00-18.00 h

Facilitated by:
Susanne Ding | Rebecca Haywood | Katrien Himpens | Patryk Jegorow | Niina Taylor (other speakers invited)

  • Legislation impacting IMP QPs
  • Third country IMP GMP inspections
  • Inspector’s view
  • Critical thinking as an IMP QP
  • Survey outcome – Clinical Trial Regulation experience
  • Quality Culture in the IMP context
  • Interactive Case Study
  • Q&A sessions

1/2 Day Pre-Conference Session

QP Oversight for "Virtual Companies" and MAHs
13.30-18.00 h

Facilitated by:
Canice Kearney | Sue Mann

  • QP responsibilities
  • Batch certification – minimum requirements & best practices
  • Control and format of Supply Chain Maps and setting the scope of responsibilities
  • Post Product Release oversight responsibilities
  • Examples and interaction

1/2 Day Pre-Conference Session

QP Liability and Indemnification
13.00-18.00 h

Facilitated by:
Carsten Coors| Afshin Hosseiny | Monika Hupfauf | Madeleine Molster

  • Civil and criminal law
  • QP liability and indemnification in international comparison (EU)
  • Risks in third countries
  • Possible legal actions against the QP
  • Internal and external liability
  • How to deal with pressure from the employer
  • Examples

Sponsoring Opportunities

For sponsoring opportunities of the QP Forum please contact admin@qp-association.eu