DR. HAKIMA IBRAHIM HOSEH
Position:
Regulatory Affairs Associate Director, Regulatory Affairs Due Diligence & Consultant for Regulatory Affairs Activities at Hikma Pharmaceuticals
Categories:
Speakers 2023
Bachelor’s degree in pharmacy/University of Jordan.
Regulatory affairs Global Certificate (RAC)USA
Hikma Pharmaceuticals (12 years)
Regulatory Affairs Associate director, RA Due diligence, and Consultant for RA activities March 2022.
RA Senior Manager for North Africa region and Due diligence 2019-2022.
RA Senior Manager at Hikma Pharmaceuticals Due diligence for under licensed products since Feb 2012 – 2019.
RA Senior Manager of MENA July 2011-Feb 2012.
JFDA (20 Years)
Head of registration department at Jordanian food and drug administration.
Drafted many of JFDA regulatory guidelines as Bioequivalence, stability, CTD, Biosimilars, GMP and Tech transfer, value added medicine VAM.
Head of bioequivalence assessment Committee 1997-2011
Head of Vaccines and Sera, biological products committee 2008-2011
Head of Cosmetic and Medical devices unit and head of the committee 1995-2005
Head of GMP and Site accreditation 2001-2005
Head of Renewal committee 2002-2004
Pricing Department 1994-2003
Narcotic Department 2004-2006
Speaker in many regulatory conferences.
Middle east CTD trainer /AUPAM
Head of Scientific committee /AUPAM organize and prepare 19 AUPAM conferences 2001-2019
Member in local and international organizations
Regulatory Affairs Professionals Society (RAPs),
Canadian Association of Professionals in Regulatory Affairs (CAPRA)
Arab Union of Pharmaceutical Manufacturers (AUPAM),
Jordan Pharmaceutical Association (JPA)