Day I
08:00-09:00 Registration
09:00-09:30 Welcome, introduction and opening remarks
09:30-10:30 The universally unrecognized assumption in calculating organ clearance and extraction ratio: implications for BA/BE determinations, Leslie Benet (USA)
10:30-11:00 BCS and Biowaivers: Regulatory updates", Vinod Shah (USA)
11:00-11:30 Coffee Break
11:30-12:00 Modern mechanistic oral Bioequivalence (BE): in vitro predictive dissolution (iPD) methodologies, Jozef Al-Gousous (Jordan)
12:00-12:30 Different regulatory approaches for evaluation of BE studies for DPI drug products, A. Atilla Hincal (Turkey)
12:30-13:00 Cholesterole targeted nanoparticles to overcome multidrug resistance in cancer, Erem Bilensoy (Turkey)
13:00-14:00 Lunch Break
14:00-14:30 Regulatory and Scientific Concepts Underlying 505(b)(2) and VAM Applications, Suliman Al-Fayoumi (Jordan)
14:30-15:00 Supercritical fluid technology shows promising potentials for enhancement of dissolution for Class II drugs, Rana Obaidat (Jordan)
15:00-15:30 Equivalence testing of inhalation products, Darragh Murnane (UK)
15:30-16:00 Coffee Break
16:00-16:30 The use of saliva instead of plasma as a surrogate in drug Bioavailability and Bioequivalence studies in humans, Nasir Idkaidek (Jordan)
16:30-17:00 Biopharmaceutical relevance of in vitro release and skin penetration studies in topical product development, Sevgi Gungor (Turkey)
17:00-17:30 Multi-Group studies in BE. To pool or not to pool? Helmut Schutz (Austria)

   

   

Day II
09:00-09:45 Importance of dissolution and drug release testing, Vinod Shah (USA)
09:45-10:30 Batch-to-batch variability of brand product and its implication on generic BE standard: PK variability of Advair Diskus and its implication on Bioequivalence assessment criteria for generic drugs, Leslie Benet (USA)
10:30-11:00 The magic buffer Bicarbonate-CO2: In vivo predictive dissolution (iPD), Jozef Al-Gousous (Jordan)
11:00-11:30 Coffee Break
11:30-12:00 The new frontier: first approval of biosimilar oncologic therapeutics in EU, Elena Wolff-Holz (Germany)
12:00-12:30 Common BA/BE inspection observations and their mitigation strategies, Ruben Ayala (USA)
12:30-13:00 Updates to ICH GCP E6 (R2) and BE Studies, Raeda Mustafa (Jordan)
13:00-13:30 Common deficiencies with BE submissions in ANDAs assessed by GCC, Nabila Al Lwatia (Oman)
13:30-14:30 Lunch Break
14:30-15:00 Bioequivalence study: similarities and differences among EMA, FDA, WHO and GCC requirements, Osama Abd Elrahaman (Oman)
15:00-15:30 Two-stage approaches for demonstration of BE, Anders Fuglsang (Denemark)
15:30-16:00 Improving the sensitivity for LC-MS quantitation of biologics fluids using Trap-and-Elute Micro LC-MS with the SCIEX OptiFlow Quant solution, Mariateresa Maldini (Germany)
16:00-16:30 The Regulatory framework of drug development: regulatory and Pharmaco-economical considerations, Emel Mashaki (Turkey)
16:30-17:00 Food effect: The combined effect of media pH and viscosity on the gastrointestinal absorption of Ciprofloxacin tablet, Abdel Naser Zaid (Palestine)
17:00- 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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