Day One
8:00-9:00 Registration
9:00-9:30 Welcome, Introduction and opening Remarks.
9:30-10:15 Food, acid supplementation and drug absorption - a complicated gastric mix: a randomized control trial,  Leslie Benet (USA)
10:15-11:00Drug delivery to the brain: novel opportunities and considerations,  Turgay Dalkara (Turkey)
11:00-11:45Bioequivalence assessment of topical formulations,  Murray Ducharme (Canada)
11:45-12:00 Coffee Break
12:00-12:30ICH M9 BCS Based Biowaiver Guideline,  Mehul Mehta (USA)
12:30-13:00The need of multiple dose bioequivalence studies for prolonged-release generic products, Alfredo Garcia-Arieta (Spain)
13:00-13:30Relevant physiological variables to design in vivo predictive dissolution methods, Maria Del Val Bermejo (Spain)
13:30-14:30Lunch Break
14:30-15:00Health Authorities
15:00-15:30 Health Authorities
15:30-16:00 Health Authorities
16:00-16:30 Coffee Break
16:30-17:00 Developing clinical endpoint bioequivalence study protocols from FDA product specific guidance, Jack McLane (USA)
17:00-17:30 Drug product development – Best practices in the current Quality by Design Paradigm,  Shadi Madieh (Jordan)
17:30-18:00Evolving science and equivalence of intravenous iron, James Polli (USA)


Day Two
9:00-9:45pAUC, needed for ensuring bioequivalence,  Mehul Mehta (USA)
09:45-10:30 Discriminating Bioavailability from Clearance Changes for Oral Drug-Drug Metabolic Interactions,  Leslie Benet (USA)
10:30-11:15Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products, Murray Ducharme, (Canada)
11:15-11:30Coffee Break
11:30-12:00Role of drug release in Complex Generics, Vinod Shah (USA)
12:00-12:30Factors Affecting Nanoparticle-Bound Drug Bioavailability and Bioequivalence,  Erem Bilensoy (Turkey)
12:30-13:00Data Extrapolation from Pilot to Pivotal Bioequivalence studies, issues to be considered when evaluating pilot BE results,  Sami Qassim (Jordan)
13:00-14:00 Lunch Break
14:00-14:30
Biosimilars: 10 years on.. Scientific Thinking,  Rodeina Challand (UK)
14:30-15:00Establishing “finger-print like” biosimilarity. Critical analytical characterisation steps for biosimilar assessment,  Fiona Geer (UK)
15:00-15:30 Biosimilar: Switching and Interchangeability,  Rodeina Challand (UK)
15:30-16:00Coffee Break
16:00-16:30
In vivo relevant in vitro characterization methods and their application to inhalation product development, Marten Svensson (Sweden)
16:30-17:00De-risking inhalation product development through mechanistic computer models - in silico biopharmaceutics,  Per Bäckman (Sweden)
17:00-17:30Fraud and manipulation in bioequivalence trails,  Anders Fuglsang (Denmark)
17:30:-18:00Closing Remarks

About The conference

The Theme of this conference is the regulatory aspects related to bioequivalence and the objective is to discuss current international trends and updates in bioequivalence assessment, biowaivers, bioanalytics, dissolution and procedures. 

This is one of the most important events planned for this year in the region due the presence of international, well-known, keynote speakers, regulatory bodies and the participation and support of international associations like AAPS, EUFEPS,  FIP and TUFTAD. The conference will provide a unique opportunity for regulators, members of the pharmaceutical industry and academics in MENA region to interact with international experts and obtain information on current and innovative trends in the areas of bioequivalence, biowaivers, bioanalysis, and dissolution testing.

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