EUFEPS Network Conference on

New Regulations in Bioequivalence:
Revised European CHMP Note for Guidance

June 17-18 • 2008 • Maritim Kurhaushotel • Bad Homburg • Germany

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Scope & Aim & Objectives
The CPMP Note for Guidance on the investigation of bioavailability and bioequivalence is presently under revision. Key issues for this process have previously been published by EMEA in a CHMP concept paper. Following this proposition, the current regulatory requirements will be systematically reviewed and specified more precisely according to the current state of science and technology. Essential open questions include the necessity of multiple dose studies for bioequivalence assessment and investigations for the characterisation of special dosage forms, e.g. or orodispersible tablets. Additionally a specific draft Note for Guidance is announced on bio-waivers based on the Biopharmaceutics Classification System (BCS). Such Guideline does not exist in Europe so far and, thus, appropriate regulations should be defined for regulatory purposes.

The intention of this conference is to give scientists from pharmaceutical industry and academia the chance to discuss the open issues with representatives from regulatory agencies involved in the revision process. 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 Conference is designed to meet the requirements and expectations of professionals from academia, generic and research based industry, 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.

Conference Sessions
• BCS-based Biowaiver – substance and product characteristics
• BCS-based Biowaiver – unresolved issues
• Bioequivalence of orodispersible tablets
• Necessity of multiple dose studies
• Summary Presentations & Consensus Discussion, Conclusions and Recommendations

Scientific and Planning Committee
Gerald Beuerle, ratiopharm, Ulm, Germany
Henning Blume, SocraTec R&D, Oberursel, Germany (Conference Co-Chair)
Erich Brendel, Bayer HealthCare, Leverkusen, Germany
Andrzej Dzierbicki, Polpharma, Warsaw, Poland
Hilda Koeszegi-Szalai, National Institute of Pharmacy, Budapest, Hungary
Hans H. Linden, EUFEPS, Stockholm, Sweden
Henrike Potthast, BfArM, Bonn, Germany (Conference Co-Chair)
Tomas Salmonson, Medical Products Agency, Uppsala, Sweden
Hans Schaefer, Boehringer Ingelheim, Biberach, Germany
Clive Wilson, University of Strathclyde, Glasgow, United Kingdom

Preliminary Programme

Opening and Welcome
EUFEPS President and Conference Co-Chairs

Session I: BCS-based Biowaiver – substance and product characteristics
Session Co-Chairs
Henrike Potthast, BfArM, Bonn DE &
José Morais, University of Lisbon, Lisbon PT
Additional Panel Members
Dirk Barends, RIVM, Bilthoven NL &
Vinod Shah, FIP, North Potomac MD USA
Rapporteur
Werner Weitschies, University of Greifswald, Greifswald DE

• Assessment of solubility: Experimental setting and conclusion
  TBA
• Absorption vs. permeability: Need-to-know vs. nice-to-know
  Hans Lennernäs, Uppsala University, Uppsala SE
• Potential impact of excipients on drug absorption
  Vinod Shah, FIP, North Potomac MD USA
• Potential impact of excipients and size/shape of dosage form on GI transit
  Werner Weitschies, University of Greifswald, Greifswald DE
• How similar is similar enough in dissolution testing?
  Panos Macheras, University of Athens GR

Session II: BCS-based Biowaiver – unresolved issues
Session Co-Chairs
Henrike Potthast, BfArM, Bonn DE &
José Morais, University of Lisbon, Lisbon PT
Additional Panel Members
Bertil Abrahamsson, AstraZeneca, Mölndal SE &
Clive Wilson, University of Strathclyde, Glasgow UK
Rapporteur
Erich Brendel, Bayer HealthCare, Leverkusen DE

• Relevance of polymorphic forms and different salts
  Julia Schulze Nahrup, GenPlus, Munich DE
• Importance of transporters and drug metabolism
  José Morais, University of Lisbon, Lisbon PT
• Implications of linear Pharmacokinetics
  Vincenzo Re, GlaxoSmithKline, Harlow UK
• Extension to weak acid of Class-II?
  Bertil Abrahamsson, AstraZeneca, Mölndal SE
• Extension to Class-III drugs?
  Henning Blume, SocraTec R&D, Oberursel DE
• Useful information from animal data?
  Clive Wilson, University of Strathclyde, Glasgow UK

Session III: BCS-based Biowaiver – unresolved issues
Session Co-Chairs
Jan Welink, Medicines Evaluation Board, Den Haag NL &
Monica Edholm, Medicines Product Agency, Uppsala SE
Additional Panel Members
Jennifer B. Dressman, University of Frankfurt DE &
Hans Lennernäs, Uppsala University, Uppsala SE
Rapporteur
Gerald Beuerle, ratiopharm, Ulm DE

• In-vitro characterisation: are standard dissolution tests appropriate and how to set specifications?
  Jennifer B. Dressman, University of Frankfurt, Frankfurt DE
• Administration conditions: standard design (single dose, fasted, 240 ml of water) appropriate? Impact of administration with or without water?
  Andrzej Dzierbicki, Polpharma, Warsaw PL
• Food interactions: necessity to investigate intake with and without breakfast?
  Christiane Rordorf, Novartis, Basel CH (invited)
• Orodispersible tablets with class-I drugs - biowaiver possible?
  Dirk Barends, RIVM, Bilthoven NL

Session IV: Necessity of multiple dose studies
Session Co-Chairs
Alfredo Garcia, AEMPS, Madrid ES &
Lazlo Tothfalusi, National Institute of Pharmacy, Budapest HU
Additional Panel Members
Sebastian Harder, Institute of Clinical Pharmacology, Frankfurt DE &
Henning Blume, SocraTec R&D, Oberursel DE
Rapporteur
Andrej Dzierbicki, Polpharma, Warsaw PL

• The regulatory concept (Europe vs. USA): Why multiple dose studies?
  Alfredo Garcia, AEMPS, Madrid ES
• Impact of multiple dosing on intra-subject variability and discriminatory power
  Lazlo Tothfalusi, National Institute of Pharmacy, Budapest HU
• Waiver of multiple dose studies in BE assessment? PK characteristics and acceptance criteria appropriate in single dose studies in order to assure BE also at steady state?
  Sebastian Harder, Institute of Clinical Pharmacology, Frankfurt DE
• Non-linearity of pharmacokinetics – when are steady state studies recommended?
  Jan Welink, Medicines Evaluation Board, Den Haag NL

Session V: NSummary Presentations & Consensus Discussion, Conclusions and Recommendations
Moderators
Henning Blume, SocraTec R&D, Oberursel DE &
Jan Welink, Medicines Evaluation Board, Den Haag NL

Exhibition Information

Health Links has been contracted as the Exhibition Organiser. Please direct all inquiries regarding exhibition and sponsorship to Health Links (channey@health-links.co.uk), Windsor House, 11A High Street Kings Heath, Birmingham B14 7BB, United Kingdom. Tel +44 208 7496471, Fax +44 121 2483390. Website www.health-links.co.uk

How to Apply for Space
Application for stand space must be made on the “Application and Contract” form. Every effort will be made to accommodate exhibitors request for space and position. The exhibition stands and space are assigned on a “first come – first served” basis.

Sponsorship Opportunities
To sponsor this Conference and by this enable additional quality meetings on key topics, contact the Executive Director, Hans H Lindén (hans.linden@eufeps.org), or Chris Hanney at Health Links (see above).

Language
English will be the language of the Conference. No simultaneous translation will be provided.

Organiser
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 10+ member institutions. There are around 600 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 conferences 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.

Conference Venue & Bad Homburg
The Conference will take place at the Maritim Kurhaushotel which is situated right in the heart of the city of Bad Homburg, Ludwigstraße 3, 61348 Bad Homburg v.d.H. Germany. Phone +49 (0) 6172 660-0, Fax +49 (0) 6172 660-100. Bad Homburg can be reached by car or light rail (S-Bahn) from the Frankfurt Main Station (Haupbahnhof) in 15-30 minutes, depending on traffic and train connections.

Charming contrasts characterise Bad Homburg. It combines cultivated tradition with the vibrant spirit of today. Everybody who plunges into this cosmos will immediately feel good, it’s concluded. Recovery from daily routine and work, diversion, fun, entertainment – Bad Homburg offers thrill and recreation in many places. In the mineral springs, body, mind and soul regenerate. Playing tennis on the oldest courts throughout the world or golf on Germany’s first course at the spa gardens and the New Course on the Taunus hillside, respectively, is on offer. Culture and exclusive gastronomy, shopping and games: sights of the former emperor’s bath combine sophisticated cultural events and cheerful festivals. Spending time is easy due to a variety of elegant restaurants, street cafés and bars. The shopping mile Louisenstraße and its side roads come up with “Shopping with style”.

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.

Registration Fees (EUR)

Corporate Sponsorship Rate: 10 % reduction of fee/s – AstraZeneca, Bayer HealthCare, GlaxoSmithKline, Pfizer, Polpharma, and ratiopharm

The registration fee (EUFEPS Membership 10% reduction) includes all Conference documentation, all coffee breaks, three lunches and one Reception buffet. The cost for hotel accommodation and travel is not included in the registration fee.

Hotel Reservation
A number of hotel rooms have been reserved at hotels at preferential rates for the Conference. The hotels are all situated in the city centre of Bad Homburg and the Conference venue is accessible with public transportation or by foot.

The rates above are per room, per night, including breakfast and VAT. Hotel accommodation will be reserved and confirmed only when Congrex Sweden AB has received your full pre-payment of the total cost of the accommodation. Congrex Sweden AB reserves the right to book another hotel if the desired accommodation should be fully booked. After May 5, accommodation and rates will be confirmed according to availability. All reservations are handled by Congrex Sweden AB. Possible changes of your hotel reservation as well as cancellation must be made in writing to Congrex Sweden AB. Please do not contact the hotel directly.

Useful Addresses

EUFEPS Member Societies

EUFEPS and Network Sponsors