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.
Market Approval Online
Want to have a look at the way we teach online?
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
Non-profit 25% discount
Apply regulatory guidelines
Through the course I learned how to find and apply regulatory guidelines to evaluate nonclinical, clinical and quality drug data, which will help in my role as hospital pharmacist/clinical pharmacist in the review committee and as clinical pharmacological researcher.
Imke Bartelink, Hospital pharmacist/ clinical pharmacologist
Very relevant contemporary cases
The online Market Approval course is a very interesting and useful course, I enjoyed it a lot! Especially the relevant and contemporary cases really were of additional value.
Anna van Muyden, Director clinical development, CellPoint
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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 claims that require approval and the way to structure an approach towards
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.
The Market Approval course is accredited (38 hours) by the Dutch Association of Hospital Pharmacists (NVZA).
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