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Scope
& Aim
The European Medicines Agency (EMEA) Committee for Human Medical
Products (CHMP) released, as result of a gap analysis, a concept
paper on the “Need of a Guideline for the Validation of Bioanalytical
Methods” in December 2008. All interested parties were invited
to provide input by the end of March 2009. Having collected and
collated all input, the CHMP subcommittee released a Draft Guideline
in November 2009, which is now in the cycle of consultation, until
the end of May 2010, i.e. for final comments.
The aim of this Workshop is to discuss the current scientific knowledge
in the area of bioanalysis, the regulatory requirements and their
subsequent translation into the work in the bioanalytical laboratory.
Examples of topics to be discussed include the GLP-status of the
process of method validation; acceptance criteria of methods to
be used in the area of chromatography based and ligand-binding based
assays; incurred sample reproducibility (ISR; study sample reanalysis
for PK purposes; and re-integration, to list only a few).
The intention of this Workshop is to give scientists from industry and academia, managers and representatives of company regulatory functions the opportunity to discuss the new regulation with representative from regulatory authorities in Europe. Input for the Workshop Programme includes comments submitted to the organisers in the run-up phase to the event. All participants are invited to present their views and suggestions, based on own experience, during the discussion, and to support these proposals by experimental data.
Although the forthcoming guidance will be new for the area of the European Union, it is not built from the very beginning. The Federal Drug Administration (FDA), as the regulatory agency in the USA, started in the early 1990ies with conferences and workshops on bioanalytical method validation and study sample analysis resulting in the current “Guidance for Industry – Bioanalytical Method Validation”, as of 2001. As there was no other regulatory guidance outside the USA available, this has been widely used and accepted as standard by the global bioanalytical community. Now, after being close to 10 years in use – and a number of white papers – it will be updated.
Who
should attend?
The Workshop is organised as an open plenary discussion forum to
meet the requirements and expectations of professionals from the
generic and the research based industry, CROs, academia and regulatory
agencies. Department heads, project managers, bioanalytical scientists
and consultants in R&D, in regulatory affairs, pharmacokinetics,
clinical studies, and biostatistics and so forth should attend in
order to contribute with their experience with the scientists from
European regulatory agencies. All delegates are invited to contribute
actively to the scientific discussions and to support the process
toward science driven regulations.
Open
Discussion Forum Sessions and Leadership
Each one of the three-hour forum discussion sessions, will be co-chaired
by one representative of EBF, EMEA and EUFEPS, normally, and start
with a thirty-minutes background presentation on the chapter topics
to be discussed. Other additional presentations will also be inserted.
Call
for Commentaries (10 minutes presentations)
In order to stimulate discussions, the Organising Committee is inviting
registered delegates to provide commentaries in 10 minutes session
specific presentations. The presentations should provide the view
of the presenter and/or its organisation on which behalf she/he
is presenting and should preferentially be data based. Presentations
will be selected, on the basis of the abstract, as will for what
session the presentation will be accepted. These presentations are
strongly limited to 10 minutes each. No commercial advertisement
will be allowed.
Please submit your abstract, of no more than 200 words, and your full address, by March 22, 2010, to the Organising Committee at: eufeps@congrex.com indicating the name of the workshop (EBF & EUFEPS Workshop on EMEA Draft Guideline on Validation of Bioanalytical Methods).
The acceptance of your presentation will be communicated by March 29, 2010. Accepted presentations should be sent, in common Microsoft Office format applications as Power Point, Excel or Word, to: eufeps@congrex.com as well, by April 6, 2010.
Conference
Co-chairs
Dr. Erich Brendel, Bayer Schering Pharma, Berlin, Germany
(also EUFEPS BABP Network)
Dr. Berthold Lausecker, F. Hoffmann-La Roche, Basel, Switzerland
(also EBF)
Dr. Christoph Siethoff, Swiss BioQuant, Reinach, Switzerland
(also CROs)
Preliminary Programme
| Thursday, April 15, 2010 | |||
| Time | Chair (Organisers) | Co-chair (EMEA) | |
| 09:00 09:15 |
Welcome
and Introduction Including goals, objectives and structure of the workshop |
Erich
Brendel, Berthold Lausecker Christoph Siethoff |
Jan
Welink Olivier Le Blaye Jérôme Barré |
| 09:15 10:15 |
Plenary
Background, including legal basis and regulatory needs CHMP Working Party Representative (20 min, Jan Welink) EBF representative (20 min, Berthold Lausecker) EUFEPS representative (20 min, Erich Brendel) |
Erich Brendel | Jan Welink |
| 10:15 10:45 |
Coffee-Break |
||
| 10:45 12:45 |
Session
I – General Aspects on Validation of Bioanalytical Methods Reference standards, integration of chromatography based and ligand-binding based assays, stability testing, assay precision and accuracy testing, full validation, partial validation, cross validation CHMP problem statement (10 min) EBF-EUFEPS position (10 min) Up to 4 Presentations (each 10 min) Open discussion (60 min) |
Christoph Siethoff | Jérôme Barré |
| 12:45 13:45 |
Lunch Break |
||
| 13:45 15:45 |
Session
II – Method Validation of Chromatography Based Assays
(Small Molecules) Matrix effect selectivity LLOQ determination CHMP problem statement (10 min) EBF-EUFEPS position (10 min) Up to 4 Presentations (each 10 min) Open discussion (60 min) |
Berthold Lausecker | Jan Welink |
| 15:45 16:15 |
Coffee
Break |
||
| 16:15 18:15 |
Session
III – Method Validation of Assays for Ligand Binding Based
Assays (Large Molecules) Parallelism and dilution integrity, LLOQ determination, selectivity testing CHMP problem statement (10 min) EBF-EUFEPS position (10 min) Up to 4 Presentations (each 10 min) Open discussion (60 min) |
Margarete Brudny-Klöppel | Jan Welink |
|
Reception |
|||
| Friday, April 16, 2010 | |||
| Time | Chair (Organisers) | Co-chair (EMEA) | |
| 09:00 10:30 |
Session
IV (1) – Analysis of Study Samples Incurred Sample Reanalysis, Reanalysis of study samples, Integration, Acceptance criteria, Multi-analyte assays, Sequence design, Carry-over assessment, Assay range changes CHMP problem statement (10 minEBF-EUFEPS position (10 min) Up to 3 Presentations (each 10 min) Open discussion (40 min) |
Gabriele Rohde | Olivier Le Blaye |
| 10:30 11:00 |
Coffee-Break |
||
| 11:00 12:30 |
Session
IV (2) – Analysis of Study Samples Study Report, Assay Report CHMP problem statement (10 min) EBF-EUFEPS position (10 min) Up to 3 Presentations (each 10 min) Open discussion (40 min) |
Gabriele Rohde | Olivier Le Blaye |
| 12:30 13:30 |
Lunch Break |
||
| 13:45 15:45 |
Wrap-up and Closing Remarks | Erich
Brendel, Berthold Lausecker, Christoph Siethoff |
Jan
Welink, Olivier Le Blaye, Jerome Barré |
| Workshop
Facilitators Moderators: Howard Hill & Kamal Midha Rapporteur: Henning Blume |
|||
Workshop
Leaders and Contributors
Jérôme Barré, Centre Hospitalier Intercommunal,
Créteil, France
Henning Blume, Socratec R&D, Oberursel, Germany
Erich Brendel, Bayer Schering Pharma AG, Wuppertal, Germany
Margarete Brudny-Kloeppel, Bayer Schering Pharma AG, Berlin,
Germany
Howard Hill, Huntington Life Science, Huntington, United
Kingdom
Berthold Lausecker, F. Hoffmann-La Roche Ltd, Basel, Switzerland
Olivier Le Blaye, AFSSAPS, Saint Denis, France
Kamal Midha, University of Saskatchewan, Saskatoon, Canada
and FIP, The Hague, The Netherlands
Gabriele Rohde, Bayer Schering Pharma AG; Wuppertal, Germany
Christoph Siethoff, Swiss BioQuant AG, Basel, Switzerland
Jan Welink, The Medicines Evaluation Board (MEB), The Hague,
The Netherlands
Registration and Accommodation
The Registration Fee is € 450.00. It includes admission to the workshop sessions, documentation and daily tea/coffee and lunch. The Welcome Drink that will take place at the workshop venue, on April 15, 2010, at the end of the first day, is also included in the Registration Fee.
For room reservations at the venue or nearby hotel, please make direct contacts with the reservation departments of, for example:
Sheraton Hotel Brussels
Tel + 32 2 2243111
Email reservations.brussels@sheraton.com
www http://www.starwoodhotels.com/sheraton/index.html
Thon Hotel Brussels
City Centre
Tel + 32 2 2051511
Email brusselscitycentre@thonhotels.be
www http://www.thonhotels.be/brusselscitycentre
For workshop leaders and contributors, a number of rooms have been
blocked at the Sheraton Hotel Brussels (see Online Registration
Form).
Conference
Co-chairs
Dr. Erich Brendel, Bayer Schering Pharma, Berlin, Germany
(also EUFEPS BABP Network)
Dr. Berthold Lausecker, F. Hoffmann-La Roche, Basel, Switzerland
(also EBF)
Dr. Christoph Siethoff, Swiss BioQuant, Reinach, Switzerland
(also CROs)
Plan
to join!
Consult the EBF Website or EUFEPS Online for updates!
EBF – European Bioanalysis Forum
Email europeanbioanalysisforum@gmail.com
EBF Website www.europeanbioanalysisforum.eu
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The European Federation for Pharmaceutical Sciences – EUFEPS
SE-175 72 Järfälla (Stockholm) Sweden
Tel +46 8 50582040 Fax +46 8 4113217 Email secretariat@eufeps.org
