Hanan kakish

Hanan F. Kakish is a pharmaceutical leader with over 27 years of experience in drug development, GMP compliance, and regulatory affairs across MENA, US, and European markets. She currently serves as an independent Pharmaceutical Consultant and has previously held prominent roles, including Technical Director at Amman Pharmaceutical Industries and Medical Research Scientist for the USFDA. Her expertise encompasses new generic product development, clinical and analytical monitoring of Bioequivalence (BE) and biowaiver studies, technology transfer, and contract manufacturing. She holds profound knowledge of post-approval changes and stringent GMP requirements, including the control of nitrosamine impurities and data integrity, in strict alignment with US FDA, EMA, JFDA, and SFDA guidelines. As an accomplished speaker and trainer at over 30 international and domestic conferences, she brings exceptional hands-on regulatory and technical knowledge to her instruction. A patented inventor and published author on drug regulations, she delivers highly practical, regulation-focused training designed to build robust pharmaceutical capacity and ensure industry compliance.

Experience

27+ Years

Pharmaceutical professional with advanced skills in drug development, GMP requirements, and regulatory guidelines across MENA, US, and European markets.

Industry Background

Pharmaceutical Development & Regulatory Consultancy

Progressed through senior leadership roles, including Technical Director at Amman Pharmaceutical Industries, R&D Manager at Jordan River Pharmaceutical Industry, and Medical Research Scientist at the USFDA, currently serving as an independent consultant.

Academic Background

M.Sc. in Pharmaceutical Technology

Holds an M.Sc. in Pharmaceutical Technology with Honor from Jordan University of Science and Technology, a B.Sc. in Pharmacy from the University of Jordan, and is a Certified Clinical Research Associate (CCRA).

Areas of Contribution