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.

Blended learning

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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

  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 product value.

Your teacher

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development

Requirements

  • at least a master's degree in a subject related to (bio)medical science.
  • a few years of relevant working experience.
  • no previous experience with market approval is required.

Market Approval contributors

Market Approval

Bruno Vandermeulen

IP Lawyer - Member of the Brussels Bar


Independent IP practitioner

On-campus

Market Approval

Nacer Lounis

Senior Principal Scientist


Janssen Pharmaceutica

On-campus

Market Approval

Tine de Marez

Senior Director, Compound Development Team Leader TB


Johnson & Johnson

Market Approval

Bert Leufkens

Professor of Pharmaceutical Policy and Regulatory Science and Former Chair of Medicines Evaluation Board


Utrecht Institute for Pharmaceutical Sciences (UIPS)

Market Approval

Henk Schuring

VP-Head Rare Nephrology


Sanofi Genzyme

Market Approval

Sjaak Bot

VP, Head of EMEA Regulatory Affairs


Janssen

Market Approval

Bernd van der Meulen

Professor of Comparative Food Law


European Institute for Food Law / Renmin University of China Law School

Market Approval

Frank Landolt

V.P. intellectual property and legal


Ablynx N.V.

On-campus

Market Approval

Erik Niks

Neurologist - Pediatric neurologist


Leiden University Medical Center

On-campus

Market Approval

Piet Hinoul

Global Head, Pre-Clinical, Clinical and Medical Affairs


J&J Ethicon

On-campus

Market Approval

Ad Sitsen

Owner


ClinPharMed Consultancy for Drug Development

Market Approval

Eline Bunnik

Assistant professor Medical Ethics and Philosophy of Medicine


Erasmus MC

Market Approval

Maurits Westerik

Senior Counsel


Bird & Bird

Market Approval

Andrea Kamage

Patent Group Leader


Johnson & Johnson

Market Approval

Bart Swinkels

Partner


NLO

Market Approval

Karin Verzijden

Food and Pharma Lawyer


Axon Lawyers

On-campus

Market Approval

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development


Paul Janssen Futurelab & Eagle Pharma Consult

Market Approval

Kees Recourt

Investment Manager


Mibiton Foundation

Market Approval

Paul Stoffels

Chief scientific officer


Johnson & Johnson

Market Approval

Tom Huizinga

Head of the Department of Rheumatology


Leiden University Medical Centre

On-campus

Market Approval

Marcel Kenter

Director


Paul Janssen Futurelab Leiden

On-campus

Market Approval

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery


Janssen Pharmaceutica NV

On-campus

Market Approval

Andreas Wallnöfer

General Partner


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

On-campus

Market Approval

Justin Hay

Pharmacokinetics Assessor


Medicines and Healthcare products Regulatory Agency

On-campus

Market Approval

André Elferink

Clinical epidemiologist


Dutch Medicines Evaluation Board

On-campus

Market Approval

Rob Zuiker

Senior Clinical Scientist


CHDR

On-campus

Market Approval

Barbara J. van Zwieten-Boot

Vice Chair


Medicines Evaluation Board, The Netherlands

Market Approval

Hans-Georg Eichler

Senior Medical Officer


European Medicines Agency

On-campus

Market Approval

Robert Klautz

Thoracic Surgeon


Leiden University Medical Centre

On-campus

Market Approval

Matthijs Moerland

Research Director Translational Biomarkers


CHDR

Market Approval

Joris Rotmans, MD, PhD

internist-nephrologist


LUMC

On-campus

Market Approval

Janneke Meulenberg

CEO


Arthrogen

Market Approval

Inge de Lepeleire

Director Translational Pharmacology


MSD Europe

On-campus

Market Approval

Koos Burggraaf

Research Director CVS & Metabolism


CHDR

Market Approval

Johan Garssen

Director Immunology Platform


Danone/Nutricia Research

On-campus

Market Approval

Ingrid de Visser

Senior Clinical Scientist


CHDR

Market Approval

Rick Kuntz

Senior Vice President and Chief Scientific, Clinical and Regulatory Officer


Medtronic

On-campus

Market Approval

Geert Jan Groeneveld

Research Director CNS


CHDR

Market Approval

Oliver Bisazza

Director Regulatory Policy


Medtronic

Market Approval

Saco de Visser

Teacher and Clinical Pharmacologist


Paul Janssen Futurelab Leiden

On-campus

Market Approval

Adam Cohen

CEO and clinical pharmacologist


Centre for Human Drug Research

Market Approval

Richard Shull

Head of Deal Structuring and Trading Fundamentals


Shell

Market Approval

Pierre Peeters

Former site head early stage development


Organon

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