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 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.
Your teacher
Ineke Jonker-Hoogerkamp
Consultant Regulatory Affairs and Drug Development
Market Approval contributors
On-campus
Nacer Lounis
Senior Principal Scientist
Janssen Pharmaceutica
On-campus
Tine de Marez
Senior Director, Compound Development Team Leader TB
Johnson & Johnson
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
Frank Landolt
V.P. intellectual property and legal
Ablynx N.V.
On-campus
Erik Niks
Neurologist - Pediatric neurologist
Leiden University Medical Center
On-campus
Piet Hinoul
Global Head, Pre-Clinical, Clinical and Medical Affairs
J&J Ethicon
On-campus
Ad Sitsen
Owner
ClinPharMed Consultancy for Drug Development
Eline Bunnik
Assistant professor Medical Ethics and Philosophy of Medicine
Erasmus MC
Maurits Westerik
Senior Counsel
Bird & Bird
Andrea Kamage
Patent Group Leader
Johnson & Johnson
Bart Swinkels
Partner
NLO
Karin Verzijden
Food and Pharma Lawyer
Axon Lawyers
On-campus
Ineke Jonker-Hoogerkamp
Consultant Regulatory Affairs and Drug Development
Paul Janssen Futurelab & Eagle Pharma Consult
Kees Recourt
Investment Manager
Mibiton Foundation
Paul Stoffels
Chief scientific officer
Johnson & Johnson
Tom Huizinga
Head of the Department of Rheumatology
Leiden University Medical Centre
On-campus
Marcel Kenter
Director
Paul Janssen Futurelab Leiden
On-campus
Koen Andries
VP Scientific Fellow Infectious Diseases Discovery
Janssen Pharmaceutica NV
On-campus
Andreas Wallnöfer
General Partner
BioMed Partners Venture Capital (former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd.)
On-campus
Justin Hay
Pharmacokinetics Assessor
Medicines and Healthcare products Regulatory Agency
On-campus
André Elferink
Clinical epidemiologist
Dutch Medicines Evaluation Board
On-campus
Rob Zuiker
Senior Clinical Scientist
CHDR
On-campus
Barbara J. van Zwieten-Boot
Vice Chair
Medicines Evaluation Board, The Netherlands
Hans-Georg Eichler
Senior Medical Officer
European Medicines Agency
On-campus
Robert Klautz
Thoracic Surgeon
Leiden University Medical Centre
On-campus
Matthijs Moerland
Research Director Translational Biomarkers
CHDR
Joris Rotmans, MD, PhD
internist-nephrologist
LUMC
On-campus
Janneke Meulenberg
CEO
Arthrogen
Inge de Lepeleire
Director Translational Pharmacology
MSD Europe
On-campus
Koos Burggraaf
Research Director CVS & Metabolism
CHDR
Johan Garssen
Director Immunology Platform
Danone/Nutricia Research
On-campus
Ingrid de Visser
Senior Clinical Scientist
CHDR
Rick Kuntz
Senior Vice President and Chief Scientific, Clinical and Regulatory Officer
Medtronic
On-campus
Geert Jan Groeneveld
Research Director CNS
CHDR
Oliver Bisazza
Director Regulatory Policy
Medtronic
Saco de Visser
Teacher and Clinical Pharmacologist
Paul Janssen Futurelab Leiden
On-campus
Adam Cohen
CEO and clinical pharmacologist
Centre for Human Drug Research
Richard Shull
Head of Deal Structuring and Trading Fundamentals
Shell
Pierre Peeters
Former site head early stage development
Organon