Essam Ghanem | Head of Drug Safety and Pharmacovigilance (DSPV)

Essam Ghanem, Head of Drug Safety and Pharmacovigilance (DSPV), VIGI-CARE

Essam GHANEM is an experienced physician and Qualified Person for Pharmacovigilance with almost 34 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Clinical Research Organisations. Around 8 years working experience as EUQPPV and as consultant Safety physician in the Pharmaceutical Industry. At present time, Essam Ghanem is the head of Drug Safety and Pharmacovigilance department at the CRO company Keyrus Biopharma (BE, FR, CA, LEB, TN)(*). Membership owner of European society of CRO Federation (EUCROF) Working Group (PVWG)


Drug Safety World Day 2 @ 15:20

Structured benefit-risk assessments – How different pharmaceutical companies are implementing new FDA guidance

  • Regulatory and industry experiences with approaches to structured benefit-risk assessments 
  • Approaches to incorporating patient perspectives into structured benefit-risk assessment 
  • Exploring available methods to advance structured benefit-risk assessment

Drug Safety World Day 2 @ 16:00

Safety signal management and Pharmacovigilance system compliance – key points to drive success from a European Perspective

  • Risk mitigation during Medicines products life cycle-New Era for pharmacovigilance compliance 
  • Stakeholders’ engagement strategy in healthcare industry – decision making hierarchy
  • Medicinal products benefit risk assessment - Health authorities’ cluster activities

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