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