Market Approval Online

Authority 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 Market Approval program at Paul Janssen Futurelab Leiden provides “learning-by-doing” training to ambitious postgraduate biomedical researchers who wish to further their career and increase their knowledge on authority approval and regulatory affairs. The program focuses on how to guide your biomedical intervention along the milestones of its lifecycle in an efficient  and timely manner.

In this five-week online Futurelab course, biomedical professionals 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. Finally, 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.

For your assistance, a Futurelab Market Approval Navigator (MAN) has been developed, to support you in the classification of your product and to assist with the authority, legislation and regulatory guidances applicable to your product and its relevant stage of development. The MAN tool is accessible for course participants of the online course Market Approval.

A multifaceted online course

In this online course, a variety of exercises will help you to understand the dynamics of market approval in realistic scenarios based on real-world case studies. In addition, the online course uses a wide variety of teaching methods including animations, tutorials, articles, interviews with industry, regulatory affairs experts, and authorities, Futurelab talks, self-assessments, tools, quizzes, assignments, online discussions with fellow course participants, and feedback from Futurelab experts.

Study time

You will be expected to spend approximately 5 hours per week for five consecutive weeks on this course.

Online exam

Your understanding of the course material will be assessed by an online exam. You will need access to a computer with webcam, a stable internet connection, a clean desk, and a private room. Participants will be monitored by a professional invigilator via webcam during the exam. After passing the exam, you will obtain a Paul Janssen Futurelab certificate and will be eligible to apply for the on-campus Market  Approval course.

Learning outcomes

Upon completion of this online course, you will have a clear understanding of building a market approval strategy and the do’s and don’ts to pass these mandatory approvals for your biomedical invention. Specifically, you will be able to:

1. Identify the essential characteristics (claims) of a product;
2. translate these claims to a product profile and design a market approval strategy;
3. optimize the market approval process with information from authorities and competitors;
4. effectuate authority advice meetings;
5. use market approval to optimize the product value.