Market Approval
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.

We are developing this course
Fill in your email address to stay updated
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.
I know enough, let's
Market Approval contributors

Bert Leufkens
Professor of Pharmaceutical Policy and Regulatory Science and Former Chair of Medicines Evaluation Board
Utrecht Institute for Pharmaceutical Sciences (UIPS)

Henk Schuring
VP-Head Rare Nephrology
Sanofi Genzyme

Sjaak Bot
VP, Head of EMEA Regulatory Affairs
Janssen

Bernd van der Meulen
Professor of Comparative Food Law
European Institute for Food Law / Renmin University of China Law School

Eline Bunnik
Assistant professor Medical Ethics and Philosophy of Medicine
Erasmus MC
On-campus

Ineke Jonker-Hoogerkamp
Consultant Regulatory Affairs and Drug Development
Paul Janssen Futurelab & Eagle Pharma Consult