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The Open Discussion Forum will open on Wednesday, February 23, 2011 at 9 am, and it will close on Thursday, February 24, 2011, at 5 pm.
Scope
& Aim
A concept paper was recently published by the European Medicines
Agency on the need for revision of the CPMP Note for Guidance on
modified release oral and transdermal dosage forms. The aim of this
open forum is to discuss the relevant issues on specific regulations
and open questions for the assessment of bioequivalence of modified
release products in order to contribute scientifically to the development
of the forthcoming draft guideline. The scientific community is
invited to share their experience with the scientists of regulatory
agencies. The intention of this Forum is therefore to give
scientists from pharmaceutical industry and academia the chance
to present their views – including experimental results –
during the discussions. Based on the existing experience derived
from bioavailability and bioequivalence (BA/BE) studies performed
by pharmaceutical companies with their development products, the
scientific rationale for appropriate requirements for the approval
of medicinal products in the European Union should be defined.
Who
should attend?
This Forum is designed to meet the requirements and expectations
of professionals from academia, generic and research based industry,
CRO and regulatory authorities. Heads of department, project managers,
scientists and consultants in R&D, formulation development,
quality control, regulatory affairs, pharmacokinetics, or clinical
studies should attend in order to share their experience in the
field with regulatory scientists from the European Agencies. All
participants will have the chance to contribute actively to the
scientific discussions in order to achieve consensus in open issues
in BA/BE, or to learn facts and trends in the field from presentations
and discussions.
Scientific
and Planning Committee & BABP Network Leadership
Gerald Beuerle, ratiopharm, Ulm DE
Henning Blume, SocraTec R&D, Oberursel DE
Erich Brendel, Bayer Schering Pharma, Wuppertal DE
Andrzej Dzierbicki, Polpharma, Warsaw PL
Hilda Koeszegi-Szalai, National Institute of Pharmacy,
Budapest HU
Hans H. Lindén, EUFEPS, Stockholm SE
Henrike Potthast, BfArM, Bonn DE
Tomas Salmonson, Medical Products Agency, Uppsala SE
Hans Schaefer, Boehringer Ingelheim, Biberach DE
Clive G. Wilson, University of Strathclyde, Glasgow UK
Forum
Co-chairs
Henning Blume, SocraTec R&D, Oberursel DE
Jan Welink, Medicines Evaluation Board, The Haag NL
| Welcome and Introductions |
| •
Goals, objectives and structure of the Forum Co-chairs |
| Session I: In-vitro vs. in-vivo characterisation of MR preparations |
| Session Co-Chairs: Henrike Potthast, BfArM, Bonn DE and Erich Brendel, Bayer Schering Pharma, Wuppertal DE |
| •
In-vitro dissolution testing: Method development and importance
of biorelevant test conditions Sandra Klein, University of Greifswald, Greifswald DE |
| •
Setting specifications for dissolution testing of modified-release
formulations Alexander Pontius, Bayer Schering Pharma, Berlin DE |
| •
Establishing in-vitro/in-vivo correlations: Concepts
and improvement (average IVIVC vs. individualised approach) Clive G. Wilson, University of Strathclyde, Glasgow UK |
| •
Dissolution data supporting variations: Opportunities and limitations Theresa A. Shepard, MHRA, London UK |
| •
Dissolution testing in case of MR products: Current regulatory
perspective and open issues Henrike Potthast, BfArM, Bonn DE and Alfredo Garcia, AEMPS, Madrid ES |
| Session II: Assessment of bioequivalence for special MR preparations |
| Session Co-Chairs: Henning Blume, SocraTec R&D, Oberursel DE and Juergen Schomakers, BfArM, Bonn DE |
| •
Transdermal Delivery Systems: Pharmaceutical equivalence –
bioequivalence – therapeutic equivalence Juergen Schomakers, BfArM, Bonn DE |
| •
Bioequivalence of transdermal delivery systems: Necessity for
replicate design and assessment of product-specific within-subject
variability? Andrzej Dzierbicki, Polpharma, Warsaw PL |
| •
TTS with different dose strengths: Dose proportionality and
extrapolation of BE data Christian Zurth, Bayer Schering Pharma, Berlin DE |
| •
Assessment of bioequivalence of MR products for parenteral administration,
e.g. liposomal preparations: Determination of free vs bound/encapsulated
compound Henning Blume, SocraTec R&D, Oberursel DE |
| •
Assessment of bioequivalence of implants: Appropriate study
design, parameters and acceptance criteria Helmut Schuetz, BEBAC, Vienna AT |
| •
Future perspective in BE assessment of parenteral modified release
preparations José Morais, University of Lisbon, Lisbon PT |
Day 2 Preliminary Programme
| Session III: Food effect studies and enteric-coated products |
| Session Co-Chairs: Jan Welink, Medicines Evaluation Board, The Haag NL and Clive G. Wilson, University of Strathclyde, Glasgow UK |
| •
Understanding ‘dose dumping’ assessment and interpretation
of significant increase of plasma concentrations after high
fat meals Werner Weitschies, University of Greifswald, Greifswald DE |
| •
Food effect studies: Improvement by body weight adjusted meal
size and restrictive standardisation of meal schedule on study
days Barbara Schug, SocraTec R&D, Oberursel DE |
| •
Requirements for drugs with specific administration recommendations
(e.g. after meal) and interactions with drugs affecting gastro-intestinal
function Hans Lennernäs, Uppsala University, Uppsala SE |
| •
In-vivo characterisation of enteric-coated products: Single
unit vs. multiple unit forms and food effects Erich Brendel, Bayer HealthCare, Wuppertal DE |
| •
Food effect studies and characterisation of enteric-coated products:
Current regulatory thinking and open issues Jan Welink, Medicines Evaluation Board, The Haag NL |
| Session IV: Pharmacokinetic characteristics for MR products and assessment of bioequivalence |
| Session Co-Chairs: Monica Edholm, Medicines Product Agency, Uppsala SE and Gerald Beuerle, ratiopharm, Ulm DE |
| •
Pharmacokinetic parameters for modified-release drug products Laszlo Endrenyi, University of Toronto, Toronto CA |
| •
Necessity of multiple dose studies: Reliability and limitations
of extrapolations based on single dose data Corina Becker, Bayer Schering Pharma, Wuppertal DE |
| •
Design requirements, acceptance criteria for bioequivalence
assessment of MR formulations Susana Almeida, Tecnimede, Abrunheira Sintra PT |
| •
MR products with different dose strengths: Extrapolation between
strengths, bracketing concept and selection of strength(s) to
be tested Gerald Beuerle, ratiopharm, Ulm DE |
| •
Bioequivalence requirements for MR products: Current regulatory
thinking and open issues Christoph Baumgaertel, Austrian Medicines and Medical Devices Agency, Vienna AT |
| Wrap-up
and closing Co-chairs |
Programme
Information
For update and even more detailed programme, as available, see this
website, or contact the Organisers (full address below).
Language
English will be the language of the Workshop. No simultaneous translation
will be provided.
Organisers
EUFEPS (European Federation for Pharmaceutical Sciences) was founded
in 1991. Its mission is to advance excellence in the pharmaceutical
sciences and innovative drug research and to represent the interests
of scientists engaged in drug research and development, drug regulation
and drug policymaking. Currently, it links scientific societies
and associations in 24 European Countries, and 15 member institutions.
There are around 400 individual members, and EUFEPS Networks are
growing in numbers. The purpose of the networks is to join scientists
together. A mission of the BABP Network is to provide an opportunity
for EUFEPS members to get to know each other, to explore important
issues in bioavailability, bioequivalence and biopharmaceutics through
Forums and workshops and ultimately to propagate learning through
various published media. The effect of these activities will be
to help Europe to lead debate rather than work in a reactive mode,
confident that resolutions are well-rehearsed and strongly scientifically
justified.
Forum
Venue & Location
The Forum will take place at the Majestic Hotel & Spa, Barcelona,
Spain. The Majestic Hotel & Spa is located in the very centre
of Barcelona, on Paseo de Gracia in walking distance to the Ramblas.
From the Airport, e.g. take the Airport Train towards the city and get off at train station Passeig de Gràcia. The Hotel Majestic is within walking distance, located on the same street one block away.
Registration
and Hotel Reservation
Click
here for Registration.
| Discussion
forum Registration fees (incl. VAT) |
EUFEPS
Members (on/before December 13, 2010) |
EUFEPS
Members (after December 13, 2010) |
Standard Fee (on/before December 13, 2010) | Standard
Fee (after December 13, 2010) |
| Industrial Delegate | 950 EUR | 1050 EUR | 1200 EUR | 1300 EUR |
| Academic Delegate | 450 EUR | 550 EUR | 550 EUR | 650 EUR |
| Government Delegate | 450 EUR | 550 EUR | 550 EUR | 650 EUR |
| Student and PhD Delegate | 200 EUR | 200 EUR | 250 EUR | 250 EUR |
Rates include daily, tea and coffee breaks and lunches as well as
a welcome reception buffet dinner on Wednesday February 23, 2011.
A number of rooms have been pre-blocked at the Majestic Hotel Barcelona and the Hotel Inglaterra for your convenience. The room blocks are available for booking until December 13, 2010. On/after this date, the room blocks will be released and availability and rates can no longer be guaranteed.
| Hotel
rates in EUR (incl. VAT) |
Single occupancy | Double occupancy | Breakfast | Available until |
| Majestic
Hotel & Spa 5* |
160 EUR/night | 180 EUR/night | Included | December 13, 2010 |
| Hotel
Inglaterra 3* |
109 EUR/night | 129 EUR/night | Included | December 13, 2010 |
Pre-Invited delegates may make their hotel reservation directly on the on-line registration form.
Registering delegates are recommended to make their reservation at any of the above hotels on the available booking form. Please note that there is a limited number of rooms available at each hotel, and allocation is made on a first-come first-served basis. Delegates are instructed to quote “EUFEPS” when making the reservation. Further details are available on the on-line registration link. Please note that all room blocks will be released on December 13, 2010.
A confirmation will be sent to you once your registration and accommodation request has been processed. Please read this carefully as it contains useful information and a summary of your booking.
Notification of cancellation must be made in writing to Congrex. Cancellation of registration will be accepted until December 13, 2010 up to which date the total amount will be refunded less EUR 50 for administrative expenses. For cancellations made after December 13, 2010 we regret that no refunds can be made. Substitutions will be allowed at any time.
Disclaimer/Liability
The Scientific and Planning Committee, and Congrex Sweden AB accept
no liability for any injuries/losses incurred by participants and/or
accompanying persons, nor loss of, or damage to any luggage and/or
personal belongings.
| Forum
Registration and Hotel Reservation Secretariat Congrex Sweden AB Attn EUFEPS PO Box 5619 114 86 Stockholm Sweden Tel +46 8 4596600 Fax +46 8 6619125 Email eufeps@congrex.com Website www.congrex.com |
EUFEPS
Meetings & Events Veddesta Business Center 175 72 Järfälla (Stockholm) Sweden Tel +46 8 50582040 Fax +46 8 4113217 Email conference@eufeps.org Website www.eufeps.org |
Forum
Venue Majestic Hotel and Spa PŠ de Gracia, 68 08007 Barcelona Spain Tel +34 93 4881717 Fax +34 93 4879790 Website www.hotelmajestic.es |
EUFEPS Member Societies
EUFEPS Sponsors
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
