11th Qualified Person Forum & Full Day Pre-Conference Session: Specific Requirements for IMPs

30 Nov - 2 Dec 2016

Madrid, Spain

Course No 15364

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

Speakers

Speakers from Authorities and Public Health Organisations:

Klaus Eichmüller, Wolnzach, c/o German GMP Inspectorate
Dr Rainer Gnibl, Government of Upper Franconia
Paul Hargreaves, MHRA and PIC/S Chairman
Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES)
Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel

Speakers from the Industry:
Justin Barry, Midatech Pharma España
Richard M. Bonner, Chairman of the EQPA, form. with Eli Lilly
Dr Susanne Ding, Boehringer Ingelheim
DI Georg Göstl, Baxter AG
Tor Gråberg, AstraZeneca
Dr Afshin Hosseiny, Tabriz Consulting
Dr Ulrich Kissel, Roche Pharma
Dr Line Lundsberg-Nielsen
NNE Pharmaplan, Aidan Madden
FivePharma, Dr Jean Denis Mallet
Form Head of the French Pharmaceutical Inspection Department
Sue Mann, Sue Mann Consultancy
Ann McGee, McGee Pharma International
form. Irish Health Products Regulatory Authority
Dr Bernd Renger, Immediate Past Chairman of the EQPA
Markus Roemer, comes compliance services
Niina Taylor, Pfizer
Andrew Teasdale, AstraZeneca
Brenda Van Assche, Janssen Pharmaceutica NV
Philippe Van der Hofstadt, B&C Group

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 critical areas of the QP’s daily work.

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

Full Day Pre-Conference Session on 30 November 2016

Specific Requirements for IMPs
Facilitated by:
IMP Working Group

New legislation impacting IMP QPs
Revised Annex 16 – lessons learned
Advanced Therapy Medicinal Products (ATMPs): regulatory requirements, GMP and the grey zones
Quality Assurance Agreement / QP to QP agreement for clinical trial manufacture
Interactive sessions
Q & A sessions

Programme QP Forum

What the QP needs to know about the new Annex 15
The influence on the work and responsibility of the QP
Expectation of an inspector
Klaus Eichmüller

What the QP needs to know about Serialisation
Implementation of the FMD: influence on batch documentation and certification
Challenges for industry and especially the QP
Jean-Denis Mallet

The Detection of falsified Medicines
The protection of the public and how the QP could support this
Paul Hargreaves

What the QP should know about Out of Stock Situations
Reasons
Management
Co-operation with the authorities
Tor Gråberg

Case Study on the QP Declaration
Challenges and possible solutions
Experiences made
Ulrich Kissel

Elemental Impurities: global Approaches and possible Solutions
What are the global challenges (different expectations, different directions?)
What is the role and responsibility of the QP?
Case study
Andrew Teasdale

1) Update on GMP-relevant Topics and what QPs are expected
to do
Discussion, questions, answers
Bernd Renger and Rainer Gnibl

2) The QP and ICH Q8/ Q12
The link to PAT and Real Time Release
Batch documentation and batch certification: things to consider
for QPs
Line Lundsberg-Nielsen and Afshin Hosseiny

3) QP Scenarios – How serious could they be?
Make decisions based on real-life situations
Sue Mann and Gillian Renouf

4) Quality Oversight of IMP QPs in global Supply Chains
Maintaining quality oversight at relevant interfaces
Testing of IMPs in various scenarios (importation, intercompany-, intracompany shipments)
QP GMP declaration for 3rd country IMP manufacture
IMP Working Group

5) Data Integrity: Why it is so important for QPs
How can the QP be sure about the integrity of data: what to focus on, what to check
Markus Roemer and N.N. (speaker invited)

6) Quality Metrics vs. Quality Parameters
What are the different expectations in the EU and the US
What is important for QPs
How to interpret data
How the QP can use quality data reviews for their daily work
Ann McGee and N.N. (speaker invited)

You will be able to attend three of these parallel sessions. Please choose the ones you like to attend when you register for the Forum.

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