Dr. Walaa Ebrahim Saber

Position: Manager of Pre-Marketing Vigilance Regulatory Affairs Administration - General Administration for Pharmaceutical Vigilance - Egyptian Drug Authority (EDA)
Categories: PV Speakers 2023

BSc. Pharm. Helwan University, Master of Business Administration (MBA) Candidate-Arab Academy for science, technology, and Maritime transport (AASTMT).

Deputy Manager of pharmaceutical vigilance.

General administration & Manager of Pre-Marketing Vigilance Regulatory Affairs Administration -General administration for pharmaceutical vigilance – Egyptian Drug Authority (EDA).

Previously Pharmacovigilance committee rapporteur & Senior PV specialist.

Walaa Ebrahim is an Administrative Manager with thirteen years of experience working within regulatory authorities. Walaa specializes in pharmacovigilance and is responsible of Supervising and management of Human, Biological, Herbal, Medical devices,  Veterinary & Biocides safety units, Supervising the development of policy proposals, Regulatory and executive regulations for pharmaceutical vigilance, Supervising the evaluation of risk-benefit balance and risk management plans for pharmaceutical products and for medical devices, Manage the Pharmacovigilance Committee and review the safety issues to be discussed by the Committee as appropriate.

  • Actively participated in EDA global benchmarking program conducted by the World Health Organization (WHO)
  • Principle contribution in the issuance and reviewing of the updated guideline on pharmacovigilance practice in Egypt (GVP)
  • Develop an appropriate Administrative & technical Manual on Pharmacovigilance practice regarding Human & Biological products illustrating the responsibilities of Marketing Authorization Holders.
  • Conducted advanced-level pharmacovigilance training sessions for pharmaceutical companies and their respective teams.
  • Participated in many EDA twining projects with other regulatory authorities.