CLINICAL EVIDENCE AND HTA IN MEDICAL DEVICES (MD) AND IN VITRO DIAGNOSTICS (IVD)

The road to market access and reimbursement in Europe

A hybrid and virtual educational and training program

Currently under development, dates will be announced shortly

The training comprises

– online lectures

– podcasts,

– virtual break – out sessions,

– group discussions

– virtual “meet the professor” tutorials

– pre-reads

 Learning objectives:

  • understand EU regulatory framework for devices and IVDs
  • understand the focus on lifecycle management
  • learn and recognize the new EU regulation of clinical evidence generation
  • understand the principles of evidence – based medicine
  • learn about the basic elements of GCP (good clinical practice)
  • learn about the concepts of clinical trials
  • understand the basic elements of health economy
  • get insights into the European challenges in health economy and value generation
  • understand the key elements of health outcome value descriptions
  • understand HTA and reimbursement processes
  • learn about the DRG systematic
  • understand all stakeholder’s perspectives in the HTA and reimbursement process
  • validate the importance of data selection and description for dossier generation
  • evaluate and discuss practical use cases
    • stakeholder mapping for HTA and reimbursement
    • Clinical trial strategy
    • Presentation of clinical evidence
    • HTA dossier generation

Course programe_CLINICAL EVIDENCE AND HTA IN MEDICAL DEVICES_2021

THE PROGRAMME IS CREATED FOR MEMBERS OF

  • Biotech/Medical Device Industry (medical, marketing, regulatory, market access, product development, general management, etc.)
  • Health Insurers
  • Health Care Providers / Commissioners
  • HTA & Consultancy Agencies
  • Educational & Research Institutions
  • Health Policy Organizations

Course Language: English

Learning outcomes verification: MCQs and documented group work

Academic valuation: 10 ECTS

Target population: international