Paul Janssen Futurelab

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.

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Market Approval Online

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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

€ 1,600

Non-profit 25% discount

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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

authorities to obtain and maintain market approval for your own biomedical research program, institute, or company. Topics that will be addressed are: What are the principles of authority approval procedures? How do you translate the target product characteristics (claims) to a dedicated market approval strategy? In addition, you will learn how to find regulatory information and to deduce the aspects relevant to accelerate the market approval process in pre-approval, market approval and post-approval stages. After completing this course, you will have a clear understanding of the principles behind the market approval system and how to create a strategy to pass the mandatory approvals for your biomedical invention.

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.

Accredited

The Market Approval course is accredited (38 hours) by the Dutch Association of Hospital Pharmacists (NVZA).

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Market Approval contributors

Juliane Bernholz

Chief Operating Officer

AM Pharma

Onno van de Stolpe

CEO

Galapagos B.V.

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