Services

World Diabetes Day 2013

World Diabetes Day 2013

For Medical Affairs I can offer the following services to you:

  • Medical input for brand plans (incl. budget control for medical activities)
  • Cross functional support to ensure alignment of medical and marketing strategies for the brand leveraging medical insights
  • Building high value-added medical programs
  • Gathering of insights for all customer related activities
  • Development of education and training materials and patient-focused tools
  • Conducting medical trainings for colleagues and medical representatives
  • Medical approval of promotional and scientific materials
  • Providing timely and informative responses to scientific queries
  • Preparing medical opinion statements as a medical expert of the company
  • Establishing cooperation with hospitals, research institutes and laboratories to identify and monitor important developments in the market
  • Managing Key Opinion Leaders (KOLs)
  • Contributing with medical input into regulatory documents
  • Representing Medical Affairs at internal and external meetings
  • Participating in advisory boards
  • Experience in a Competitive-Response Team

 

For Medical Safety I can offer the following services to you:

  • 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
  • Coordination of a risk management team and preparing/maintaining risk management files
  • Support for preparation of periodical safety reports (clinical evaluation reports, risk management reports, post-market surveillance reports)
  • Approval of marketing material
  • Member of Safety Boards and cross functional product risk analyses
  • Processing medical, safety-relevant aspects of clinical studies
  • Medical evaluation of individual case reports before submission to regulatory authorities
  • Continuous monitoring and further development regarding the safety of the product portfolio
  • Providing safety expertise to global product development teams and project teams
  • Revising, updating and implementing safety business procedures documented in business harmonized standards