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, Isadore Kanfer (Canada)
11:45-12:00 Coffee Break
12:00-12:30Developing clinical endpoint bioequivalence study protocols from FDA product specific guidance, Jack McLane (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
14:30-15:00Regulatory considerations for the submission & assessment of Bioequivalence studies: Applications & how to improve, Rana Malkawi (Jordan)
15:00-15:30 Utilization of Bioequivalence Studies and Dissolution Studies for Post Registration Regulation of Pharmaceutical Products, Saleh A. AlSuwayeh (KSA)
15:30-16:00 Additional strength Biowaiver:  Practical Regulatory Similarities & Differences Approaches, Osama Abd Elrahman (Oman)
16:00-16:30 Coffee Break
16:30-17:00 ICH M9 BCS Based Biowaiver Guideline,  Mehul Mehta (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
9:00-9:45A Thermodynamic Equivalence Testing—A Novel Approach to Establishing Bioequivalence, Sarfaraz K. Niazi (USA)
09:45-10:30 Discriminating Bioavailability from Clearance Changes for Oral Drug-Drug Metabolic Interactions,  Leslie Benet (USA)
10:30-11:15Model Integrated BE approaches for Long Acting Injectables, Murray Ducharme, (Canada)
11:15-11:30Coffee Break
11:30-12:00Role of drug release in Complex Generics, Vinod Shah (USA)
12:00-12:30An in vivo predictive dissolution methodology (iPD methodology) with a BCS Class IIb drug can predict the in vivo bioequivalence results: Etoricoxib products, Isabel Gonzalez-Alvarez (Spain)
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: 15 years of evolution,  Rodeina Challand (UK)
14:30-15:00Development of successful PBPK models, Nasir Idkaidek (Jordan)
15:00-15:30 Switching, Substitution 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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