Qualified Person Forum

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