“ Life's too short to regret the past, so be passionate on the road ahead ”


Clinical Affairs Roles


  • Medical monitoring activities for clinical trials
  • Medical interpretation of clinical trial results
  • Pharmacovigilance activities



Medical Affairs Core Business


  • Interim management Medical Affairs
  • Responsible Physician within CUP/MNP
  • Responsible for Information and Publicity


Expertise services


  • Medical trainings for different stakeholders
  • Medical assessment in due diligence activities
  • Providing medical strategy and expertise for products under development
  • Medical review of regulatory required medical and safety evaluation reports

Bio


Björn is a trained experienced pharmaceutical physician with a proven track record in clinical research, medical and safety functions, across multiple therapeutic domains within pharmaceutical industry, academic collaborative groups, and medical device companies both at national and international level.


He has a broad background in managing and designing clinical trials with oversight of Phase I to Phase IV multi-site studies for several drugs as well as classes IIb and III medical devices. He’s skilled in setting up, and keeping the medical overview of, pharmacovigilance and materiovigilance programs. He has a referenced portfolio of medical information within multiple therapeutic domains. Medical input in company strategic decisions is a cornerstone of his diligence in these matters.


Björn has a meticulous approach to scientific data without losing their overarching medical sense, leading to fast and to the point conclusions, clearly communicated with a variety of stakeholders. He embraces a proactive attitude in continuous education and motivating others to apply highest quality standards. He maintains a passion for developing innovative products and has a paramount focus on patient safety.


PoinT IMC bv

Dorpsstraat 2

3078 Kortenberg, Belgium

Cell phone: +32 473 98 31 58

VAT Nbr: BE 0652.953.817

email: info@point-imc.eu

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