Market and Patient Access in clinical research
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About this course
Reasons to attend
It is nowadays well recognized that Market Access represents a fourth hurdle after the three first ones of the registration step. Having a Marketing Authorization is not sufficient anymore to access the market. Strong data supporting the relative therapeutic value and economic value of new medicine are mandatory for a successful market and patient access.This course will provide the basics of a market access plan, from early clinical development until the first EU launch. After the course, value proposition development, pricing strategy and some other aspects of the market access process will not be a secret anymore for the attendees.The course includes cases studies, short exercises and a final evaluation to encourage understanding.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
Programme highlight
- Market access: a national competency
- General market access process
- Value proposition development
- From clinical data to the relative therapeutic value
- Key clinical parameters: impact on access
- Economic value
- Pricing strategy
- Impact of International pricing (in EU)
- Basics of budget impact calculation
- Basics of Health economic analysis
- Importance of "early market access" input.
Learning objectives
Who should attend
- Anyone who would like to understand the basics of market access in the EU
- All colleagues who are involved in the development of clinical protocols
- People responsible for strategy development in clinical research and beyond
- Medical Affairs colleagues, including MSL and KAM
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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