DR. WALAA EBRAHIM SABER

Position: Manager of Pharmaceutical Vigilance General Administration - Egyptian Drug Authority (EDA)
Categories: Speakers 2024

Bachelor’s degree in Pharmaceutical Sciences, and Master of Business Administration (MBA) Candidate-Arab Academy for science, technology and Maritime transport (AASTMT).

Previously:

  • Deputy Manager of Pharmaceutical Vigilance General administration
  • Manager of Pre- Marketing Vigilance Regulatory Affairs Administration
  • Pharmacovigilance committee rapporteur
  • Senior PV specialist. – Egyptian Drug Authority (EDA)

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 pre marketing & post marketing administrations regarding  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.

Achievements

  • A representative of EDA in WHO regulatory training in swissmedic & many other training and scientific events.
  • 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.
  • Participated in the Pharmacovigilance inspections on marketing authorization holders.
  • Conducted advanced-level pharmacovigilance training sessions for pharmaceutical companies and their respective teams.
  • Participate in many EDA twining projects with other regulatory authorities.
  • Principle contribution in developing many EDA guidelines and polices
  • Prepare and review the Standards Operating Procedures (SOPs) of whole Pharmacovigilance processes and continuously update them as appropriate.
  • Manage the Pharmacovigilance Committee and prepare safety issues to be discussed by the Committee as appropriate
  • Takes/ recommends the appropriate regulatory actions where necessary based on the continuous monitoring of the safety profile for pharmaceutical products available in Egypt.
  • Develop work strategies &plans, delegate tasks & monitor the performance.