Day One
8:00-9:00 Registration
9:00-9:30 Welcome, Introduction and opening Remarks.
9:30-10:15 Mechanistic Bioequivalence (BE): IVIVC->IVIVP (Prediction) ,  Gordon Amidon (USA)
10:15-11:00Food, Acid Supplementation and Drug Absorption – a Complicated Gastric Mix: a Randomized Control Trial,  Leslie Benet (USA)
11:00-11:45Drug delivery to the brain: novel opportunities and considerations,  Turgay Dalkara (Turkey)
11:45-12:00 Coffee Break
12:00-12:30Bioequivalence assessment of topical formulations,  Murray Ducharme (Canada)
12:30-13:00 TBC
13:00-13:30ICH M9 BCS Based Biowaiver Guideline,  Mehul Mehta (USA)
13:30-14:30Lunch Break
14:30-15:00Inspector’s expectations during BE-studies inspections – Common findings, Elham Kossary (Switzerland)
15:00-15:30 TBC
15:30-16:00 Jordan FDA
16:00-16:30 Coffee Break
16:30-17:00 Application of Q3-bioequivalence strategies for orally inhaled and nasal drug products for the US,  Jag Shur (UK)
17:00-17:30 Drug product development – Best practices in the current Quality by Design Paradigm,  Shadi Madieh (Jordan)
17:30-18:00 TBC


Day Two
9:00-9:45Discriminating Bioavailability from Clearance Changes for Oral Drug-Drug Metabolic Interactions,  Leslie Benet (USA)
09:45-10:30 Gastrointestinal Variables in vitro: The ‘Magic’ Bicarbonate Buffer , Gordon Amidon (USA)
10:30-11:15pAUC, needed for ensuring bioequivalence,  Mehul Mehta (USA)
11:15-11:30 Coffee Break
11:30-12:00Tackling the challenges of nano-medicine,  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
Development of a generic inhaled product - integrating device and formulation design, Orest Lastow (Sweden)
16:30-17:00 In vivo relevant in vitro characterization methods and their application to inhalation product development,  Mårten Svensson (Sweden)
17:00-17:30 De-risking inhalation product development through mechanistic computer models - in silico biopharmaceutics,  Per Bäckman (Sweden)
17:30:-18:00 Closing 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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