Qualified Person Forum

Programme

Click on the image to download the Qualified Person Forum 2026 programme as PDF.

Keynote: How to lead and influence People without having direct disciplinary Power
Stefanie Schubert

This year’s keynote focuses on two essential capabilities of QPs: the confidence to make the right decision even under organisational headwinds, and the ability to strategically influence stakeholders by shaping incentives so that others move with you, not against you.

GMP Update - Legislative Trends and News for the QP
Brendan Cuddy and Andreas Kraßnigg

• The topics will be based on current developments and will be defined in due time prior to the event.
  
  

Artificial Intelligence and the QP
Speakers invited

Case studies and discussion of current AI-related topics

What the QP needs to know about the Electronic Product Information ePI
Elke A. Loris

• What is the ePI?
• Current status
• What does it mean for our products?
• Digital material impact
• ePI and the release process
  
  

Case Study: The QP’s Role in a Product Transfer to a New Manufacturing Facility
Carme Espadamala Morató

• Legal and personal responsibility: What does the QP really sign for?
• How to gain real process understanding
• Defining minimum expectations before release decisions
  
  

1) Everyday Concerns for QP - Legal Pitfalls and how avoid them
Monika Hupfauf and Hanneke Later-Nijland

• Responsibility, liability, and protection mechanisms for QPs
• How QPs can strengthen their legal position in the organisation
• Whistleblowing, compliance and integrity in GMP
• Case study: QP decision-making under uncertainty, i.e. after a suboptimal GMP inspection
  
  

2) The QP Role reflected in Quality Agreements, Contracts, etc.
Ulrich Kissel, Heike Meichsner and Nina Langoth-Fehringer

• The QP’s legal and operational role
• Translating QP tasks and accountability into contractual clauses
• Identifying typical gaps between contracts and real GMP practice
  
  

3) QP Scenarios: How serious could they be?
Sue Mann and Gillian Renouf

• Discuss real-life situations involving QPs
• Explore the potential risks and impact
• Make decisions on the product(s) involved
  
  

4) Challenges for IMP QPs
IMP Working Group

• Sponsor responsibilities and sponsor release
• Early Access Treatments
• Comparators, Auxiliary Medicinal Products
  
  

5) Informed Choices when facing Risks: Risk-based Decision Making for QPs
Cheryl Chia and Aidan Madden

• What is your risk tolerance?
• How well do you know the processes?
• What risks are you choosing to accept or mitigate?
• How do the risk assessment processes at your company support you in your decision making as a QP?
  
  

6) Supply Chain, Quality and CMO Oversight for the QP
Rainer Gnibl and Susanne Müller

• Regulatory obligations on supply chain oversight and QP’s role/responsibility
• Oversight of CMOs beyond technical agreement: QP’s instruments
• Oversight of subsidiaries vs. oversight of CMOs
• Practical pitfalls
• Discussion of participant’s examples