Drug regulatory affairs Consultant in the area of clinical trials, Bioequivalence studies, Biosimilars, and cGMP with over 23 years of working experience in the academic, research, pharmaceutical industry & Drug regulatory affairs fields. A demonstrated history of working in the pharmaceuticals industry in Europe & GCC region. a Pharmacy study & a Ph.D. in Pharmacy focused on Pharmaceutical Industry from Christian Albrecht University Kiel, CAU Zu Kiel, Germany.

Outstanding Teaching Experiences in the following science fields: Clinical Pharmacy, Pharmaceuticals, Medicinal Chemistry, drug discovery, and Pharmaceutical Biotechnology.

A strong track record of achievements in my current position as a Drug Affair Consultant. My day-to-day tasks include, among others:
– Evaluation of more than 1100 GCC & Local clinical, Bioequivalence & Biowaiver (M5) studies for NDA & ANDA drug products.

– Evaluation of biotechnology & biosimilar products, including Covid-19 Vaccines, Monoclonal AB & Antiviral drugs.

– Evaluation of all SUPAC Variations types.

– Updating Local & GCC Guidelines as a member of the cGMP & Bioequivalence committees.

– Staff Training in the field of cGMP, GLP, Bioanalytical & clinical, and Bioequivalence studies.

– Updating presentations regarding the international pharma Industry Guidelines.

– Staff Training in the field of cGMP, GLP, Bioanalytical & clinical, and Bioequivalence studies.

– Updating presentations regarding the international pharma Industry Guidelines.

– Updating presentations regarding Covid-19 vaccines & treatment possibilities during the Covid-19 Pandemic time.