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)
11:00-11:15Coffee Break
11:15-12:00ICH M9 BCS Based Biowaiver Guideline,  Mehul Mehta (USA)
12:00-12:30Virtual Bioequivalence in Absence of a Unique Bio-predictive Dissolution Test: Why, and How?, Amin Rostami (UK)
12:30-13:00Relevant physiological variables to design in vivo predictive dissolution methods, Maria Del Val Bermejo (Spain)
13:00-13:30Inspector’s expectations during BE-studies inspections – Common findings, Elham Kossary (Swiss)
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 Contract Research Organizations accreditation by the Gulf Cooperation Council, Nabila Jawad Al lawati (Oman)
16:00-16:30 Coffee Break
16:30-17:00 The inspectors’ expectation for an adequate QA control of software systems’ audit trails, Isabella Berger (Austria)
17:00-17:30 Additional strength Biowaiver:  Practical Regulatory Similarities & Differences Approaches, Osama Abd Elrahman (Oman)
17:30-18:00Preparation and evaluation of vitamin c solid in oil based formulation for corneal epithelial wound healing, Hatim S. AlKhatib (Jordan)


Day Two
9:00-9:45Discriminating Bioavailability from Clearance Changes for Oral Drug-Drug Metabolic Interactions,  Leslie Benet (USA)
09:45-10:30 Model Integrated BE approaches for Long Acting Injectables,  Murray Ducharme, (Canada)
10:30-11:15Biosimilars: 15 years of evolution,  Rodeina Challand (UK)
11:15-11:30Coffee Break
11:30-12:00Bioequivalence assessment of topical formulations, Isadore Kanfer (Canada)
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
Establishing “finger-print like” biosimilarity. Critical analytical characterisation steps for biosimilar assessment, Fiona Geer, (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
De-risking inhalation product development through mechanistic computer models - in silico biopharmaceutics,  Per Bäckman (Sweden)
16:30-17:00Fraud and manipulation in bioequivalence trails,  Anders Fuglsang (Denmark)
17:00-17:30Closing Remarks
17:30:-18:00

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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