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)