EUFEPS Network Conference on:

Revision of BE Requirements for Modified Release Products

February 23-24 • 2011 • Barcelona • Spain

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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 conference 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 conference 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 Conference 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.

Conference Sessions

• In-vitro vs. in-vivo characterisation of MR preparations
• Factors affecting the in-vivo performance of MR products
• Pharmacokinetic characteristics for MR products and assessment of bioequivalence
• Assessment of bioequivalence for special MR preparations

Scientific and Planning Committee
Gerald Beuerle, Ratiopharm, Ulm, Germany
Henning Blume, SocraTec R&D, Oberursel, Germany (Conference Chair)
Erich Brendel, Bayer HealthCare, Wuppertal, 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

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Plan to join!