10th Qualified Person Forum: Full Day Session "Specific Requirements for IMPs"

10th Qualified Person Forum: Full Day Session "Specific Requirements for IMPs"

Berlin, Germany

Course No 9333


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Speakers from Authorities and Inspectorates:
Dr Rainer Gnibl
Government of Upper Franconia
Tor Gråberg
Swedish Medical Products Agency
Johanna Linnolahti
Finnish Medicines Agency (Fimea)
Mag. Dr Christina Meissner
Austrian Agency for Health and Food Safety (AGES)
Edit Szöcs
Hungarian Drug Inspectorate, National Institute of Pharmacy (NIP)

Speakers from the Industry:
Justin Barry
Midatech Biogune
Richard M. Bonner
Chairman of the EQPA, form. with Eli Lilly
Dr Christopher Burgess
EQPA, form. with Glaxo
Dr Susanne Ding
Boehringer Ingelheim
Dr Marcel Goverde
MGP Consulting
Dr Afshin Hosseiny
Tabriz Consulting
Monika Hupfauf
CHG Czernich Lawyers
Dr Ulrich Kissel
Roche Pharma
Dr Wolfgang Loh
Immune Biotec
Dr Line Lundsberg-Nielsen
NNE Pharmaplan
Aidan Madden
Sue Mann
Sue Mann Consultancy
Dr R. D. McDowall
R D McDowall Limited
Dr Bernd Renger
Immediate Past Chairman of the EQPA
Gillian Renouf
Tony Scott
Alexandra Staerk
Niina Taylor
Liz Tolan
Philippe Van de Hofstadt
B&C Group
Mary-Anne Weatherhead


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.


In the last nine years, the European QP Association Forum has been becoming a major event for European Qualified Persons.
Speakers from EMA, FDA and various national authorities as well as QPs have been sharing their view of roles and responsibilities of the Qualified Person.
Hoping to continue the success of this unique Forum, the Advisory Board of the QP Association has set up the programme at hand for the 10th QP Forum to give you an update about recent developments and important matters to consider. Representatives from the authorities as well as QPs and well-known experts will present latest issues and share their point of view. During the three pre-conference sessions and the six parallel sessions at the Forum, various case studies will be presented and discussed to come up with possible solutions.

Make use of this event by exchanging experiences with your colleagues and by establishing informal contact and networking.

I would like to invite you to this outstanding event, and I look forward to meeting you.

Best regards,
Richard M. Bonner
Chairman of the 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.


Full Day Pre-Conference Session Specific Requirements for IMPs

Facilitated by:
IMP Working Group
New legislation impacting IMP QPs
Roundtable revised Annex 16: «to delegate or not to delegate»
GDP: The distribution of IMPs
Example: How to perform a risk assessment
Investigator initiated trials: Survey results
Interactive case studies: Decision making of IMP QPs
Interactive Q & A sessions

QP Forum, 25 - 26 November 2015

Keynote: The QP Job - what about Ethics and Culture?
Comply or die?
Responsibility, confidence & dialogue: My triangle of orientation
Wolfgang Loh

The Falsified Medicines Directive: Harmonisation needed?
The Written Confirmation and the impact on global pharma
Differences of the transposition of the FMD into national law
Different countries - different approaches
The FMD: a more secure supply chain now?
Liz Tolan

The Falsified Medicines Directive: What will be important?
New packaging design and Change Control
Batch Record Review and batch release
How to handle returns (are all returns falsified medicines?)
What to do in the case of suspected falsification
Tor Gråberg

Data Integrity: what the QP needs to know
Why is it making everybody nervous?
Data Integrity in the own company
Data Integrity with suppliers and contractors
Dr Bob McDowell

PAT and Real Time Release: really a hot Topic for QPs?
What is the current status? (is anyone doing that at all?)
Things to consider for QPs
The link to process validation and master batch documentation
Dr Line Lundsberg-Nielsen

Cross Contamination Observations: what a QP can learn
Poor practices observed
Examples of deficiencies & recommendations
Recalls related to cross contamination
Risk Management

Why QPs should love Statistics (a final Presentation)
The power of statistical techniques and error theory
Statistical interpretation of data
What is necessary for QPs
Christopher Burgess

Parallel Sessions: Working on Case Studies

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

2) Annex 16 - Status quo and new tasks
QP Discretion
Ulrich Kissel and Christina Meissner

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

4) The Role of the QP at the GMP/GCP interface
Where does the IMP QP responsibility end?
Where and when should the IMP QP be involved in the clinical trial (e.g. Site-to-site transfer, temperature excursions, shelf life extension, complaint handling, joint GMP/GCP inspections etc.)
Managing incidents at the GMP/GCP interface
IMP Working Group

5) The QP/GDP Interface
Where does responsibility end and when does it come back?
QP and RP co-operation
Deviations in the supply chain: reporting and handling
Johanna Linnolahti and Aidan Madden

6) The QP and Contracts
What does a QP need to know?
EU regulations vs. non-EU regulations - what counts?
How to keep the overview
Involvement of the QP
Afshin Hosseiny and Monika Hupfauf

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.

Q&A Session
During the 2 days of the Forum, delegates can post their questions. The answers will be given by the expert speakers in a dedicated session and/or published in the members' area of the EQPA web-site.

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