- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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5 days to go - register NOW!
Bioavailability / Bioequivalence, Dissolution and Biowaivers
23 - 24 May 2012, Continental Zara Hotel, Budapest, Hungary
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Bioavailability / Bioequivalence, Dissolution and Biowaivers
Adressing the pertinent issues: Biowaivers; Bioanalytical Guideline; In Silico modelling; BE Clinical Trials; In Vitro- In Vivo Correlation; Pharmacokinetics
8th annual
Bioavailability/ Bioequivalence, Dissolution and Biowaivers 2012
Real life industry examples of clinical design, biowaivers and dissolution testing for BABE and how to comply with the latest regulatory updates
Brand new for 2012:
- Prepare for the new modified release guideline with our expert panel discussion session
- Explore the latest developments and possibilities of implementing dissolution apparatus and methodology
- Find out how to design successful BABE clinical trial studies using in vitro-in vivo correlation
- Hear from clinical experts on BABE clinical trial testing in paediatric populations and patient populations
- Learn how to implement the scaling approach for your BABE studies
- Learn how to improve pharmacokinetic modelling
New Announcement: Barbara Davit from the FDA will be speaking at BABE, Dissolution and Biowaivers 2012!
Speaker Panel
Speaker Panel
Vit Perlik
Senior Clinical Development Manager
Zentiva, Sanofi-Aventis Group
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Christoph Saal
Associate Director, Molecule Characterisation
Merck KGaA
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Gerald Beuerle
Head of Clinical Development
ratiopharm GmbH, Germany
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Nikoletta Fotaki
Lecturer in Pharmaceutics
University of Bath
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Paola Tocchetti
Independent Consultant
Previously, Director Drug Metabolism and Pharmacokinetics at
NicOx Research Institute, Italy |
Christoph Baumgartel
Head of Department, Safety and Efficacy Asessment of Medicinal Products
AGES PharmMed, Austria
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Saeed Qureshi
Senior Research Scientist
Health Canada
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David Elder
Director, Scinovo, Pre-Clinical Development
GlaxoSmithKline
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Exhibitors
Promotional Participant
Media Partners
Three extra learning opportunities:
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Tuesday 22 May: Pre-conference symposium Improving Bioavailability and Bioequivalence for Poorly Soluble Compounds This symposium will include presentations from industry experts, drawing on a number of practical examples and real-life case studies with the aim of improving methods of proving BE for poorly soluble compounds (BCS class 2). Includes information on in silico methods for establishing pharmacokinetics. Together with expert leaders, the delegates will address considerations to keep in mind when performing dissolution testing and clinical studies for poorly soluble compounds. David Elder, Director Scinovo (Pre-Clinical Development), GlaxoSmithKline, UK Karin Liltorp, Analytical Chemist, Preformulation, Lundbeck, Denmark Robert Forbes, Professor of Biophysical Pharmaceutics, Bradford University
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Wednesday 23 May: Evening Seminar Y Practical examples of how to obtain a biowaiver: Beyond the regulations This workshop will provide practical advice on how to obtain a biowaiver and how to use in vivo- in vitro correlation to gain a biowaiver. The session will include discussion, real-life examples, and presentations focussing on how companies have achieved biowaiver success. Presentation topics will include:
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Thursday 24 May: Breakfast Seminar Bio-Relevant Drug Dissolution Testing for Developing and Evaluating Products Saeed Qureshi, Senior Research Scientist, Health Canada, Canada
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Reviews
"A very good combination of regulatory and generic industry input."
"A very enlightening event and a wonderful chance to meet regulators and experts in the field."
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Dates and Venues
23 May 2012 - 24 May 2012
Continental Zara Hotel, Budapest, Hungary
Contact Us
Event Registration:
Ph: +44 (0)20 7017 7823
E: registrations@informa-ls.com
Programme Information:
E: camilla.perselli@informa.com
