EUFEPS Network Conference on New Regulations in Bioequivalence: Revised European CHMP Note for Guidance June 17â18 ⢠2008 ⢠Bad Homburg ⢠Germany The Workshop opens on Tuesday, June 17, 2008 at 09:00 and closes on Wednesday, June 18, 2008, at 15:30. Scope & Aim 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 dispersible 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 product 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 â substance and product characteristics ⢠BCS-based Biowaiver â unresolved issues european journal of pharmaceutical sc iences 33 (2008 ) 462â463 doi:10.1016/S0928-0987(08)00198-X avai lab le a t www.sc iencedirect .com journal homepage: www.elsev ier.com/ locate /e jps ⢠Bioequivalence of orodispersible tablets ⢠Necessity of multiple dose studies ⢠Summary Presentations & Consensus Discussion, Conclusions and Recommendations Scientific Programme 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 Exhibition & Sponsorship Companies are welcome to participate as exhibitors and to sponsor this Conference. Contact the EUFEPS Executive Director, Hans H Lindén (
[email protected]). Mark your calendar! Plan to join! Consult the EUFEPS Online for updates! Or contact the European Federation for Pharmaceutical Sciences (EUFEPS): P.O. Box 1136 · SE-111 81 Stockholm · Sweden Tel +46 8 7235000 · Fax +46 8 4113217 Email
[email protected] · EUFEPS Online www.eufeps.org european journal of pharmaceutical sc iences 33 (2008 ) 462â463 463