Rudi Scheerlinck

Owner at Patient Safety Rudi Scheerlinck S.a.r.l.

  Switzerland

About me

Rudi Scheerlinck – Senior medical advisor and manager Rudi is an MD who holds a Post-graduate in Pharmacology and Pharmaceutical Medicine and an EMBA in International Management. He is an experienced, strong performing safety physician and manager with significant hands-on experience who can work independently, and can also mentor and upgrade existing staff (interim management). He seeks the added value for to the business via close interactions with Clinical Development (clinical studies) and Medical Affairs (product launch and post-marketing). He has a broad experience, including signal detection, medical analysis, management of safety issues, risk management. Rudi is a former Deputy EU QPPV and Head of Drug Safety, who has set up, adapted, and led medical evaluation & risk management teams at small and big pharma, covering small molecules, monoclonal antibodies, vaccines, medical devices, OTC, biosimilar, cosmetics, and food supplements. He has worked in a variety of therapeutic areas (e.g. Oncology, Dermatology, Immunology/Inflammation, Infectious, CNS, Metabolic, Cardiovascular, Gastro-intestinal, Respiratory, Urology). Across his career, he has been involved in IDMC, safety review boards, marketing authorisation applications (Summary of Clinical Safety, Clinical Overview, USPI, SmPC, CCDs, RMP), due diligences, and interactions with Health Authorities across the world. He drafted expert reports (e.g. regulatory authorities, insurance companies, legal support).

Schedule

My Session

Safety reporting requirements and safety assessments for IND studies (Dec 2025 FDA Guidance)
  • Safety Evaluation Plan
  • Safety assessments
  • Expedited reporting triggered by findings from aggregate data

Rudi Scheerlinck

Owner at Patient Safety Rudi Scheerlinck S.a.r.l.


Risk Management
Patient Safety
Post-Marketing Surveillance