Bioequivalence and Bioavailability
Gain essential advice from regulatory experts on the new bioequivalence and bioanalytical guidelines for 2010
With the arrival of 2 NEW guidelines; the long-awaited bioequivalence guideline and the bioanalytical guideline you cannot afford to miss this timely event!
Make sure you attend this year to equip yourself with the tools and the knowledge to cope with the impact of these regulatory changes and to ensure 100% compliancy.
Featured Session:
Dr Barbara Davit, Acting Director of the Division of Bioequivalence II from the office of Generic Drugs from CDER/ FDA will be presenting on the US FDA’s Bioequivalence and Bioavailability Approaches for Generic Drug Products - don't miss out on this rare opportunity to gain answers to all your bioequivalence and bioavailability questions firsthand!
Highlights of EU Pharmaceutical Law Forum 2010
Companies attending in 2009 included:
Novartis, Solvay , Boehringer Ingelheim , Orion Pharma, Hexal AG, Sandoz GmbH, Sanofi Aventis, Teva Europe, Pliva, Hexal AG, Lek Pharmaceuticals, EMEA
Homepage speakers
Homepage speakers
Barbara M Davit
Acting Director of the Division of Bioequivalence II
Office of Generic Drugs from CDER/ FDA
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Berthold Lausecker
Group Head Development Bioanalytics
Hoffmann La Roche, Switzerland
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Helmut Schütz
Director
BEBAC, Austria
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Professor Jean-Michel Cardot
Department of Biopharmaceutics and Pharmaceutical Technology
Universite d'Auvergne, France
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Kevin Ryan
Assiociate Research Fellow Analytical R&D, Worldwide Pharmaceutical Sciences (WWPS)
Pfizer, UK
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Tamas L Paal President
Scientific Board, Professor
National Institute of Pharmacy, Hungary; University of Szeged, Hungary
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Ivana Taseveska
Pharmaceutical Assessor
State Institute of Drug Control, Czech Republic
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Sponsor
Media Partners
IMPORTANT: TRAVEL UPDATES
Monday 17 May 2010:
We would like to advise delegates and speakers that although at this time there is travel disruption, the Bioequivalence and Bioavailability conference and assoicated workshops will take place as scheduled.
Alternate Travel Information. click here
FDA SPEAKER CONFIRMED
Discuss all your Bioequivalence & Bioavailability issues face to face with:
Dr Barbara Davit, Acting Director, Division of Bioequivalence II, Office of Generic Drugs, FDA, USA who will be speaking on 'Updates on the US-FDA's Bioequivalence Approaches for Generic Drug Products'.
If you have any questions you would like to submit before the event takes place please email the Conference Producer, Sahera Hossain: sahera.hossain2@informa.com
Plus Don't Miss
Pre-Conference Workshop X: Monday 17 May 2010
Design and Evaluation of BE Studies
Main topics to be covered:
• Learn which studies have to be performed for a new modified release formulation (single dose, multiple dose, food effect)
• Study design issues (guidelines, dose regimen, sample size estimation, study population, sampling time points, safety parameters, bioanalytical method, pharmacokinetic parameters, evaluation issues)
• Evaluation (safety, BE assessment, pharmacokinetic parameters, statistical assessment of bioequivalence)
• Adherence to guidelines as well as dealing with difficult questions like high variability will be examined
• Dealing with the 'unexpected'
Led by: Helmut Schütz, Director, BEBAC, Austria
Post-Conference Workshop Y: Thursday 20 May 2010
IVIVC In Practice for New Chemical Entities and Generics
Main topics to be covered:
• Overview of In Vitro & In Vivo methods
• BCS (Biopharmaceutical Classification System), permeability-solubility
• Biopharmaceutical approach: Absorption number, Dissolution number, Solubility number (An, Dn D0)
• Introduction to In Vitro & In Vivo correlation: Backgrounds of correlations
• When IVIVC could be established
• Impact of BCS on IVIVC
• Limitation of IVIVC
• Practical examples and more……
Workshop Leader: Professor Jean-Michel Cardot, Department of Biopharmaceutics and Pharmaceutical Technology, Universite d’Auvergne, France
News
Dates and Venues
18 May 2010 - 19 May 2010
Hotel Lev, Slovenia
Sponsor
Reviews
"Excellent, need to conduct more such events"
"Very informative in terms of quality of presentations/interest of topics"
