14th Qualified Person Forum
Speakers
Speakers from Authorities, Inspectorates and Associations:
Steven De Strycker, Federal Agency for Medicines and Health Products, fagg, Belgium
Klaus Eichmüller, GMP Inspector, Germany
Dr Rainer Gnibl, Government of Upper Franconia, Germany
Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES)
Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel, U.K.
Speakers from the Industry:
Justin Barry, J&JB Consulting
Anthony Bennett, Anthony Inspires
Richard M. Bonner, former Chairman of the EQPA
David Cockburn, EQPA
Dr Susanne Ding, Boehringer Ingelheim
Walid El Azab, Steris
DI Georg Göstl, Takeda
Tor Gråberg, AstraZeneca
Dr Afshin Hosseiny, ECA
Dr Ulrich Kissel, EQPA
Cristina De Simoni Klitgaard, Novo Nordisk
Line Lundsberg-Nielsen, Lundsberg Consulting
Aidan Madden, FivePharma
Sue Mann, Sue Mann Consultancy
Edel Ryan, Mylan
Niina Taylor, Pfizer
Brenda Van Assche, Janssen
Philippe Van der Hofstadt, Clinical Supplies Management
Dr Anke von Harpe, QProgress
Peter C. Zimmermann, Iskom
(other speakers invited)
Objectives
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.
Background
The QP is responsible for ensuring that each individual batch has been manufactured and checked in accordance with the requirements of the marketing authorisation (MA) and in compliance with GMP. This is how it is described in Annex 16 of EU-GMP Guidelines. The Annex also describes in detail other QP's responsibilities and activities in part 1.7.
But the QP is not responsible for everything! Most activities may be delegated and the QP can rely on the respective Pharmaceutical Quality System. How this can be done will be a central topic of this year's QP Forum.
Don't forget: "The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH)."
Make use of this event by exchanging experiences with your colleagues and by establishing informal contacts and networking. I look forward to meeting you in Munich.
Best regards,
Ulrich Kissel
Chairman of the European Qualified Person Association
Target Group
The Forum is designed for all Qualified 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.
Programme
Key Note: A Patient's View - What Dying taught me about Living
Anthony Bennett
After surviving multiple viral infections with a 10% survival rate, Anthony brings to light the importance of teamwork, from the perspective of his family and the medical professionals during his time in hospital. After listening to this session QPs should feel inspired, uplifted and proud of the work they do.
Experiences made with the MRA and post-Brexit
Tor Gråberg
Difficulties and how to overcome
(inspections, GMP certificates, importation)
What we have experienced
Problems occurred and solutions found
GMP Update Session
David Cockburn, Rainer Gnibl and Tor Gråberg
New Regulations and Guidance and their relevance for the QP
What the QP needs to know about the current Contamination Control Strategy
Walid El Azab
Development of a risk-based assessment for contamination control and sterility assurance maintenance
What the QP should be aware of before certifying products
Where the involvement of the QP is needed
Information flow
Real Time Release Testing and Certification by the QP: a next Generation Process or still Phantasm?
Line Lundsberg-Nielsen
What the QP needs to know about Annex 17, ICH Q12 and Real Time Release concepts
What is already possible - and what not
Pre-requisites, chances and challenges
What do authorities expect?
The PQR and its benefit for the QP
Klaus Eichmüller
How the PQR could be used in an efficient way and not end in a graveyard of data
Parallel Sessions: Working on Case Studies
1) Soft Skills for QPs
How to analyse communication situations
How to deescalate conflict situations
How to show self-confidence in discussions with senior management?
Richard Bonner and Peter C. Zimmermann
2) Change Control and Certification for global Markets
How to deal with change control challenges when regular approvals can take several months or years to cover all the relevant countries worldwide
How to support decision making
Ulrich Kissel and Cristina De Simoni Klitgaard
3) QP Scenarios - How serious could each issue be?
Discuss real-life situations involving QPs
Explore the potential risks and impact
Make decisions on the product(s) involved
Sue Mann and Gillian Renouf
4) Challenges for IMP QPs
Sample and documentation retention, etc.
Experience sharing, e.g. Brexit, new IMP GMP regulation
Challenges for smaller companies
IMP Working Group
5) QP Oversight
Practical aspects of keeping oversight on both external (third party) and internal (own site/ own company) QP-related processes
QP responsibilities and delegation of tasks
Edel Ryan and Anke von Harpe
6) The QP in the Pharmaceutical Quality System
Discuss how the QP can rely on a PQS and how such a system could be set up
Assistance and support for the QP
Afshin Hosseiny and Aidan Madden
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