MENA Region Professionals

Connecting experts across borders

Meet our experts

Leading the way in pharma excellence

  • Prof. Dr. Osama Abd Elrahman
    Pharmacist | Chemist | Drug Regulatory Affairs Consultant
    • Over 24 years of experience in clinical trials, bioequivalence studies, biosimilars, and cGMP.
    • Evaluated 1,400+ clinical and bioequivalence studies for NDA, ANDA, biological, and vaccine products.
    • Ph.D. in Pharmacy from Christian Albrecht University Kiel, Germany.
    • Former Associate Professor at University of Nizwa, Oman.
    • Consultant at Ministry of Health, Oman, for vaccine evaluation and regulatory affairs.
    • Expertise in biopharmaceuticals, GMP training, and international regulatory standards.
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  • Dr. Mohammad Fat'hy Elnadi
    Pharma Business & Regulatory Expert | International Trainer
    • 18+ years of experience in pharmaceutical business development, regulatory affairs, and supply chain management.
    • Regulatory Project Manager at Elrazy Pharmaceuticals – responsible for global market access strategies.
    • Expertise in CTD/eCTD submissions, quality management, and regulatory compliance.
    • MBA in progress, Pharmaceutical Science Degree from Cairo University.
    • Trainer for regulatory, quality, and supply chain courses across ASEAN, GCC, and Africa.
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  • Dr. May Ahmed
    Biosimilars & Biopharmaceuticals Expert | ICH Q3E Working Group Member
    • Head of Biosimilars & Cell-Based Analysis Unit, Egyptian Drug Authority (EDA).
    • ICH Expert in Q3E EWG, contributing to global pharmaceutical quality guidelines.
    • Ph.D. in Bioanalytical Chemistry from Cairo University.
    • Extensive experience in biosimilarity assessment, molecular characterization, and bioanalysis.
    • Researcher in biotherapeutics and oncology drug development.
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  • Dr. Hakimah Hoseh
    Regulatory Affairs & Due Diligence Consultant | Pharma Industry Expert
    • 32+ years of experience in regulatory affairs, due diligence, licensing, and technology transfer.
    • Former Regulatory Affairs and Due Diligence Associate Director at Hikma Pharmaceuticals.
    • Expert in MENA pharmaceutical regulations, including JFDA and SFDA.
    • Trainer and consultant for international regulatory compliance.
    • Speaker at global regulatory conferences and author in RAPS PAC manual book 2022.
    • Organized 20+ conferences for the Arab Union of Pharmaceutical and Medical Devices Manufacturers (AUPAM).
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  • Dr. Amr Abdel Moneim Saad
    Pharmaceutical & Drug Regulatory Affairs Expert | WHO Consultant
    • Former Associate Minister of Health for Pharmaceutical & Drug Regulatory Affairs, Egypt.
    • Founder of Egyptian Pharmacovigilance Center & VigiHub®.
    • Over 24 years of experience in drug regulatory affairs, pharmacovigilance, and policy development.
    • Ph.D. in Epidemiology from The University of Manchester, UK.
    • Developed Common Arab Guidelines for Pharmacovigilance.
    • Expertise in clinical research, pharmacovigilance, and regulatory strategy.
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  • Dr. Anas Alshishani
    Analytical Chemistry Expert | Researcher | University Professor
    • Ph.D. in Analytical Chemistry (Separation Science) from Universiti Sains Malaysia (USM).
    • Assistant Professor at Zarqa University, Jordan & Manager of the Pharmaceutical Research Center (PRC).
    • 18+ years in R&D, quality control, and pharmaceutical analysis.
    • Expert in impurity profiling, analytical method validation, and regulatory compliance.
    • Author of 13+ research papers, with an H-Index of 7.
    • Trainer for HPLC, drug degradation, regulatory analysis, and GMP compliance.
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  • Dr. Khaled Shalaby
    General Manager, Reference Laboratories, Egyptian Drug Authority
    • 26+ years of experience in pharmaceutical analysis and regulatory science.
    • Expertise in GCC cGMP inspections, ISO 17034 accreditation, and certified reference materials.
    • Bachelor’s Degree in Pharmacy from Cairo University.
    • Skilled in analytical instrumentation (HPLC, GC, UV, IR, Atomic Absorption, and Dissolution Testing).
    • Leads quality management and accreditation for pharmaceutical reference standards.
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  • Samah Shawkat
    Operational Excellence & Regulatory Expert | Medical Devices Specialist
    • Operational Excellence Manager at ICBR.
    • Former Unit Manager at the Egyptian Drug Authority (EDA) overseeing medical devices and diagnostics.
    • Expertise in ISO 10993 compliance, medical device regulations, and quality management.
    • Led initiatives for industrial localization of medical devices in Egypt.
    • Former Quality Control Specialist at NODCAR with expertise in pharmaceutical analysis.
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