Services

World Diabetes Day 2013

World Diabetes Day 2013

I can offer the following services to you:

Medical Affairs

  • Study Management and Medical Review of clinical trials
  • Medical & scientific support relating to trial results / publications
  • Medical input to develop medical brand plans (incl. budget control)
  • Cross functional support to ensure alignment of medical and marketing strategies
  • Development of education and training materials and patient-focused tools
  • Medical approval of promotional and scientific materials
  • Conducting medical trainings for colleagues and medical representatives
  • Managing Key Opinion Leaders (KOLs)
  • Contributing with medical input into regulatory documents
  • Experience in Competitive-Response Teams

 

Medical Safety

  • Member of Safety Boards and cross functional product risk analyses
  • Processing medical, safety-relevant aspects of clinical studies
  • Providing safety expertise to global product development teams and project teams
  • Revising, updating and implementing safety business procedures documented in business harmonized standards
  • Monitoring of relevant safety aspects and risk management for medical devices class II/III
  • Medical assessment and documentation of risks according to German and European medical device regulations
  • Signal detection and signal evaluation
  • Support for preparation of periodical safety reports (clinical evaluation reports, risk management reports, post-market surveillance reports)

For further details, please request my CV using the social network platforms below. I will be glad to discuss opportunities for a collaboration.