BioAvailability and BioEquivalence
Ramada Plaza Budapest
�rpád fejedelem útja 94
Budapest, Hungary
BioAvailability and BioEquivalence
Informa Life Sciences
Ramada Plaza Budapest

Schedule of Presentations:

Tuesday, May 12, 2009
08:30:00 Registration and coffee
09:00:00 Opening remarks from the Chair
09:10:00 Automation of Dissolution Testing for Screening Formulation Concepts in Early Development Geraldine Hebrard
09:50:00 Biorelevant Technologies to Support Formulations Destined for the Clinic Gorkhn Sharma-Singh
10:30:00 Morning tea and coffee
11:00:00 Generic Industry’s Perspective on the New Draft BA/BE Guidelines Gerald Beuerle
11:40:00 Industry’s Perspective on the New Draft BA/BE Guideline Evelyn Van Den Tweel
12:20:00 Lunch
13:30:00 Revised Guidelines on Therapeutic Equivalents on Inhalation Medicines – The Proof of Equivalence for Inhalation Medicines Alfredo García Arieta
14:10:00 Approaches to Solving Problems in Bioequivalence Alfredo García Arieta
14:50:00 Afternoon tea & coffee
15:20:00 Bioequivalence Strategies in Development – an Industry Perspective Áine Kane
16:00:00 Implementing BA/BE Guidelines – one Size Does Not Fit All – Sponsor’s Perspective Case Study: Shivanand Dhanure
16:40:00 From QC to QA in Bioequivalence Study Sponsoring – The Role of CRO Qualification Programs Susana Almeida
17:20:00 Closing Remarks from the Chair
17:30:00 End of Day One
Wednesday, May 13, 2009
08:00:00 Registration and coffee
08:20:00 Opening remarks from the Chair
08:30:00 Latest Regulatory Guidelines on Biowaivers and the Biopharmaceutical Classification System Ivana Taseveska
09:10:00 Industry Case Study on the Biowaiver Approach Andrea , Stosik
09:50:00 Panel Discussion on the Differences Globally in the use of Biowaivers (EU, US and ROW)
10:20:00 Morning tea and coffee
10:50:00 In silico Prediction Case Study: Neil John Parrott
11:30:00 Biosimulation in BE studies – Case Study of Insulin Tue Søeborg
12:10:00 Spotlight Session
12:40:00 Lunch
13:50:00 Case Study on an IVIVC on BCS Class II, III or IV Jean Michel Cardot
14:30:00 Use of Non-Linear Mixed Effect Models to Establish an IVIVC for a Non-Oral Dosage Form Case Study: Stefaan Rossenu
15:10:00 Afternoon tea and coffee
15:40:00 Comparability Testing for Biologics: Biosimilars János Borvendég
16:20:00 Statistical Issues in Biosimilarity Case Study: Sandro Gsteiger
17:00:00 Closing Remarks from the Chair
17:10:00 End of Conference
3D Tissue Models
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