Qualified Person Forum
The Main Conference - 28/29 November 2024
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 Qualifi ed Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons.
Forum Moderator
Aidan Madden
Programme
Click on the image to download the Qualified Person Forum 2024 programme as PDF.
Sponsoring Opportunities
If you are interested in sponsoring opportunities of the QP Forum, please contact admin@qp-association.eu.
Agenda
Opening Address
Emer Cooke
The GMDP IWG Work Programme 2024 – 2026
Brendan Cuddy
- What is the GMDP IWG and who attends it?
- Influences: what is coming in terms of new legislation that will impact on GMP, Inspectors and QP’s;
- Strategic Priorities of the GMDP IWG
- Highlights of the work programme: 2024 – 2026
- Highlights and results so far this year
- Conclusions
- Harmonisation between the Agencies
Rick Friedman (remote) - Acceptance of Annex 1
- Quality Risk Management
- Quality Systems and facility oversight
- Drug Shortages and a Relief from certain Requirements
Umberto M. Musazzi - Papers published at EU level to mitigate drug shortages
- Aspects with impact on the manufacturing sector
- Shortage management plan
- Potential flexibility in certain GMP requirements
How a Mock Recall can be performed
Jyotsna Agnihotry
- How to plan, execute and document a Mock Recall
- Flow of information before
- Role (and involvement) of the QP
The Present and Future of Digitalisation for the QP
Cheryl Chia
- What is digitalization?
- Where are we now?
- What does this mean to the QP?
- Where do we go from here?
Moderated Panel Discussion on current Developments in GMP
David Cockburn, Tor Gråberg, Andreas Krassnigg and GMP Inspectorsof the Dutch Inspectorate IGJ
Interactive Sessions
1) Remote Certification: are you ready?
Cheryl Chia and Ulrich Kissel
- Applicable guidance
- Things to consider
- Workflows needed
2) Annex 1 Implementation: Is your MIA at Risk?
Rainer Gnibl and Aidan Madden
- How to deal with gaps in the company and at CMOs
- How to mitigate risk
- How to differentiate between risk management and excuse management
- How the QP might influence risk management processes
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
- ATIMP Release
- Phase appropriate Quality Management System (QMS)
- CTA/IMPD compliance check
5) Critical KPIs for the QP
Cecilie Hejlskov and Arnoud Herremans
- KPI’s that drive good quality behavior
- How KPIs can support or undermine your role as an QP
- Visualization of KPI’s that benefit us all
6) Resilience for the QP
Sonsee Neu
- How resilience impacts decision-making
- Stress management
- Practical exercises to enhance resilience
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.