Module

Biomedical Science

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.

Requirements

  • A master’s degree in any subject related to biomedical science;
  • Several years of relevant working experience;
  • No prior knowledge or experience with market approval or regulatory affairs is required.

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Your teacher

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development

Biomedical Science contributors

Market Approval Online

Erik Niks MD PhD

Neurologist - Pediatric neurologist
Leiden University Medical Center

Market Approval Online

Piet Hinoul

Global Head, Pre-Clinical, Clinical and Medical Affairs
J&J Ethicon

Market Approval Online

Prof. Ad Sitsen MD PhD

Owner
ClinPharMed Consultancy for Drug Development

Market Approval Online

Wim Parys

Head of R&D Global Public Health
Janssen Pharmaceutica

Market Approval Online

Eline Bunnik

Assistant professor Medical Ethics and Philosophy of Medicine
Erasmus MC

Market Approval Online

Maurits Westerik

Senior Counsel
Bird & Bird

Market Approval Online

Andrea Kamage

Patent Group Leader
Johnson & Johnson

Market Approval Online

Bart Swinkels

Partner
NLO

Market Approval Online

Karin Verzijden

Food and Pharma Lawyer
Axon Lawyers

Market Approval Online

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development
Eagle Pharma Consult

Market Approval Online

Kees Recourt

Investment Manager
Mibiton Foundation

Market Approval Online

Paul Stoffels

Chief scientific officer
Johnson & Johnson

Market Approval Online

Tom Huizinga

Head of the Department of Rheumatology
Leiden University Medical Centre

Market Approval Online

Marcel Kenter

Director
Paul Janssen Futurelab Leiden

Market Approval Online

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery
Janssen Pharmaceutica NV

Market Approval Online

Andreas Wallnöfer

General Partner
BioMed Partners Venture Capital (former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd.)

Market Approval Online

Justin Hay

Pharmacokinetics Assessor
Medicines and Healthcare products Regulatory Agency

Market Approval Online

André Elferink

Clinical epidemiologist
Dutch Medicines Evaluation Board

Market Approval Online

Rob Zuiker

Senior Clinical Scientist
CHDR

Market Approval Online

Barbara J. van Zwieten-Boot

Vice Chair
Medicines Evaluation Board, The Netherlands

Market Approval Online

Hans-Georg Eichler

Senior Medical Officer
European Medicines Agency

Market Approval Online

Robert Klautz

Thoracic Surgeon
Leiden University Medical Centre

Market Approval Online

Matthijs Moerland

Research Director Translational Biomarkers
CHDR

Market Approval Online

Joris Rotmans, MD, PhD

internist-nephrologist
LUMC

Market Approval Online

Janneke Meulenberg

CEO
Arthrogen

Market Approval Online

Inge de Lepeleire

Director Translational Pharmacology
MSD Europe

Market Approval Online

Koos Burggraaf

Research Director CVS & Metabolism
CHDR

Market Approval Online

Johan Garssen

Director Immunology Platform
Danone/Nutricia Research

Market Approval Online

Ingrid de Visser

Senior Clinical Scientist
CHDR

Market Approval Online

Rick Kuntz

Senior Vice President and Chief Scientific, Clinical and Regulatory Officer
Medtronic

Market Approval Online

Geert Jan Groeneveld

Research Director CNS
CHDR

Market Approval Online

Oliver Bisazza

Director Regulatory Policy
Medtronic

Market Approval Online

Saco de Visser

Head of Education and Clinical Pharmacologist
Paul Janssen Futurelab Leiden

Market Approval Online

Adam Cohen

CEO and clinical pharmacologist
Centre for Human Drug Research

Market Approval Online

Richard Shull

Head of Deal Structuring and Trading Fundamentals
Shell

Market Approval Online

Pierre Peeters

Former site head early stage development
Organon

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