Market Approval is mandatory at various milestones in the development of your novel biomedical intervention and need to be passed to move your product to the market and beyond.
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Market approval is mandatory at various milestones in the development of your novel biomedical intervention and need to be passed to move your product to the market and beyond. The program focuses on how to guide your biomedical intervention along the milestones of its life cycle in an efficient and timely manner.
What makes this course special?
The course introduces biomedical professionals to the world of authorities and regulatory affairs. It is interesting for anyone who aims to bring a new medical intervention to market now or in the future. You will learn to identify the product claims that require market approval and how to define a strategy to obtain market approval alongside the developmental program of your product. We will address the authority landscape (e.g. EMA, FDA, Notified bodies, EFSA), legislation, regulatory dossiers, authority advice meetings, product labels and approaches for device-drug combinations and other novel/complex products that require a tailored market approval approach. To deepen your acquired skills, scenarios based on real-world cases are included in exercises to illustrate the complexity and dynamics involved in obtaining and maintaining market approval of biomedical interventions.
What will you learn?
In this 5-week online course, you are introduced to the world of authorities and regulatory affairs for novel medical interventions – medicinal products, medical devices and medical nutrition. You will learn to identify the product
5 things you will take away from this course
- Identify the essential characteristics (claims) of a product.
- translate these claims to a product profile and design a market approval strategy.
- optimize the market approval process with information from authorities and competitors.
- effectuate authority advice meetings.
- use market approval to optimize product value.
Market Approval contributors
Chief Operating Officer
Onno van de Stolpe
Professor of Pharmaceutical Policy and Regulatory Science and Former Chair of Medicines Evaluation Board
Utrecht Institute for Pharmaceutical Sciences (UIPS)
VP-Head Rare Nephrology
VP, Head of EMEA Regulatory Affairs
Bernd van der Meulen
Professor of Comparative Food Law
European Institute for Food Law / Renmin University of China Law School
Assistant professor Medical Ethics and Philosophy of Medicine
Consultant Regulatory Affairs and Drug Development
Paul Janssen Futurelab & Eagle Pharma Consult