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

QP Forum 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

EMA Presentation
Brendan Cuddy

  • Topic to be announced soon

Harmonisation between the Agencies
Rick Friedman (remote)

  • Acceptance of Annex 1
  • FDA’s role in PIC/S
  • FDA inspections in the EU

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
EQPA Board and GMP Inspectors

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.

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