Expertise

Executive Leader with 25+ years of experience in Global Clinical Development & Clinical Operations in Pharmas and Biotechs.

Research and Development of Innovative, Orphan, Combination & OTC Drug Products and Medical Devices in Ophthalmology.

Professional Experience

  • Bfaminvest – GCP Expert, tailor-made services in preclinical and clinical development
  • Oxurion NV – Global Head of Clinical Operations and Medical Affairs, Leuven
  • EyeD Pharma – Head of Clinical Development, Liège
  • Santen – Sr Director, Clinical Operations EMEA, Munich
  • TRB Chemedica Int’l – Ass. Director R&D Ophthalmology, Geneva

Expertise

  • Ophthalmology
  • Orphan Drug diseases
  • Drug-Device Combination products
  • Fixed Combination medicinal Products
  • Medical Devices
  • US, EU, India
  • ICH – Good Clinical Practice (GCP) E6 (R3)
  • ISO 14155: Clinical investigation of medical devices for human subjects — Good clinical practice
  • CRO Management and Oversight
  • Risk Management in clinical trials
  • Strategies to increase patient enrollment

Background

  • PhD in Pharmaceutical Sciences, Geneva, Switzerland
  • Pharmacist Degree (PharmD), University of Louvain, Belgium
  • BSc in Pharmacy, University of Namur, Belgium

Publications

  • Coming soon…

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