Live Online Conference: 15th Qualified Person Forum

26/27 November 2020

Course No 17532

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Rainer Gnibl, Government of Upper Baviaria, Germany
Anne Hayes, Irish Health Products Regulatory Authority (HPRA) and PIC/S
Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES)
Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel, U.K.
Richard M. Bonner, former Chairman of the EQPA
David Cockburn, EQPA
Cristina De Simoni Klitgaard, Novo Nordisk
Sipi Dhaliwal, Merck Sharp & Dohme
Dr Fabienne Diekmann, Diekmann Lawyers
Dr Susanne Ding, Boehringer Ingelheim
DI Georg Göstl, Takeda
Tor Gråberg, AstraZeneca
Dr Afshin Hosseiny, ECA
Patryk Jegorow, Takeda
Dr Ulrich Kissel, EQPA
Karsten Lollike, Novo Nordisk
Aidan Madden, FivePharma
Sue Mann, Sue Mann Consultancy
Dr Wolfgang Schumacher, form. F. Hoffmann-La Roche
Peer Schmidt, AbbVie
Kristina Smith Hansen, Leman
Niina Taylor, Pfizer
Brenda Van Assche, Janssen

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

This year is a special year and will be remembered for a long time. The Covid-19 pandemic is shaping our professional environment as well as our private lives. But life goes on and we, especially as QPs, need and want to educate ourselves.

Therefore the EQPA Board has decided to offer this year's QP Forum also as a Live Online Conference. All lectures and sessions of the main Forum will be held consecutively and can be attended by all participants - either directly on site in Berlin or live online at your screen.

You can benefit from the Early Bird offer and register for the QP Forum now and decide later how you participate.

Make use of this event and continue with your ongoing training and further improve your skills and knowledge.

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 developments regarding the duties and responsibilities of Qualified Persons.

Q&A Session

During the 2 days of the Forum, delegates can post their questions in writing. The answers will be given by the expert speakers in a dedicated session and/or published in the members’ area of the EQPA website.

Programme

Key Note: Quality Culture - Kristina Smith Hansen

Why the focus on Quality Culture?
Why is it important for QPs?
Who creates culture and how?
The role of the QP within the company’s culture.

The PIC/S GMP Inspection Reliance Initiative - Anne Hayes

How PIC/S and ICMRA aim to maximise inspection resources for GMP compliance of overseas facilities
The possibility of desk-top assessments of GMP compliance of overseas facilities
Benefits for both Industry and Regulatory Authorities

QP between Import and Export – the Impact from Annex 21 and Brexit - Tor Gråberg and Sipi Dhaliwal

Applicable and new Guidance
Current and future role of the QP in import and export activities
Necessary QP Supply Chain oversight
The QP/RP interface
Practical examples

The Role of the QP in the Company (A Code of Practice for QPs) - Richard M. Bonner, Georg Göstl and Ulrich Kissel

Various interfaces
Hierarchy and discretionary power
Organisation-chart and job description
How to foster decision making and autonomy
How to fulfil QP duties in a global Environment

Challenges for IMP QPs - IMP Working Group

Use of comparators in clinical studies and IMP QP involvement
Identification of potential risks for IMP QPs and their mitigation strategies
Relationship between Sponsor and IMP QPs

QP Scenarios – How serious could each issue 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

Liability and Delimitation of Responsibilities within a Company - Fabienne Diekmann

Delimitation of Responsibilities within
- same site
- different sites in the same Country
- different legal entities in different countries
Delimitation of responsibilities without contract
Allocation of responsibilities and liability to Head of QC, Head of Production and MAH
Amending employment contracts to include delimitation of responsibility

The QP - QPPV Interface - Cristina De Simoni Klitgaard and Karsten Lollike

Interfaces and delimitation of the responsibilities
Why co-operation is important (with examples)
How to foster co-Operation
Benefits and limits

The new Annex 1 – what QPs should expect - Aidan Madden and Andreas Krassnigg

The most important changes
Influence on the QP certification process
Risk-based approach

Demystify Data Integrity: What’s really important for QPs - Wolfgang Schuhmacher and Rainer Gnibl

Data Governance and batch certification
Batch Record and Audit Trail Review
What are the critical data?

How to certify Drug-Device Combinations (DDCs, Combination Products) - Peer Schmidt

What the QP needs to know about the new Medical Devices regulations
Responsibilities of the QP when certifying DDCs
How to ensure that the medical device part meets the general EU safety and performance requirements
How to prove compliance with medical device regulations

Frequently asked Questions - David Cockburn

Benefits of the EQPA discussion forum
Answers to the most frequent questions
Interesting issues and possible solutions

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