Qualified Person Forum
The Main Conference - 27/28 November 2025
Objective
This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the challenging parts of the QP’s daily work.
Target Group
The Forum is designed for all Qualified Persons and aspiring Qualified Persons. It will also appeal to upper management functions plus regulatory authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons.
Forum Moderator
Aidan Madden
Sponsoring Opportunities
If you are interested in sponsoring opportunities of the QP Forum, please contact admin@qp-association.eu.
Programme
Click on the image to download the Qualified Person Forum 2025 programme as PDF.
Agenda
Opening Address: 50 Years QP – 20 Years EQPA
David Cockburn and Ulrich Kissel
- A short story about the evolvement of the role of the QP: where does it come from, where is it going?
- Different approaches in Europe and the world
- Achievements of the EQPA
Key Note: An Inspirational Talk on Resilience, Courage and Motivation
Patricia Kelly
General GMP Update – News for the QP besides the big Topics
Andreas Krassnigg
- Current legal developments
- EMA and IWP news
- Trusted Partners news
What the QP needs to know about Root Cause Analysis
Cecilie Hejlskov
- Handling of unexpected deviations according Annex 16 (3)
- How can a QP be sure that a deviation has been thoroughly investigated and the root cause corrected?
- How to assess the impact of deviation?
Decentralised Manufacturing – what is it and how will it develop?
N.N.
- How ATMPs lead the way
- Potential applications in Biotech and classical Pharma
- Key enablers for decentralised manufacturing
- Challenges and outlook
Drug Shortages: what the QP needs to know
Cheryl Chia and Umberto M. Musazzi
- Drug shortage policy in the EU: what’s important for the QP
- How to deal with the requirements
- Potential flexibility in certain GMP requirements
2026 and Beyond: Emerging Trends in the Pharmaceutical Industry
Paul Palmer
- Advancements in digital health
- Rise of personalised medicine
- Sustainability in manufacturing
Interactive Sessions
1) Sharing and Delegating QP Responsibilities
Ulrich Kissel, Nina Langoth-Fehringer and Aleksandra Szymczak
- „The QP” according to EU GMP is not really uniform
- How to avoid that more than one QP in the organisation does not cause confusion?
- Supply chains involving many MIAHs
- How to split responsibilities and delegation of tasks?
- Exchange of best practices
2) How to deal with significant Non-Conformances?
Georg Göstl and Rainer Gnibl
- Open experience sharing between QPs: discussing everyday headaches
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
5) Role of the QP in Supply Chain Oversight
Aidan Madden and N.N.
- How should the traceability of the supply chain of the active substance and medicinal product be documented to support the QP?
6) Navigating Resource Challenges as a QP
Eike Feldmann and Charis Schmidt
- Science-based leadership strategies to manage high workloads with limited time and resources
- Key frameworks
- Solutions to improve efficiency, decision-making, and team collaboration under pressure
Q&A Session
During the 2 days of the Forum, delegates can post their questions verbally or in writing. The answers will be given by the expert speakers in dedicated sessions.