Clinical Product Development
Clinical development is crucial part of R&D for new products. Enhance your skills in selecting safe and informative starting doses using NOAEL and MABEL methods, and gain insight in project valuation calculations through case studies based on real-world R&D projects.
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Clinical Product Development Online
Clinical product development is a vital phase in bringing new products to the market and patients. Learn from inspiring real-world case studies.
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Gain insights into the challenges of product development spanning from discovery, (non-)clinical development and market approval.
Learn the roles and responsibilities of Principle Investigators (PIs), Sponsors, Institutional Board of Directors, DSMCs, IECs/IRBs, Clinical Trial Authorities and other stakeholders.
Gain the skills to determine a safe starting dose for a First-in-Human Trial using the NOAEL or MABEL method.
Develop critical reading skills by analyzing a real-world Investigator’s Brochure for a First-in-Human trial.
Clinical Product Development On-campus
prerequisite: online course
Everything from
Online +
Experience the challenge of decision making on R&D projects
Learn from the successes and failures of real-world R&D projects
Learn from your group members in small, interdisciplinary working groups
Hear about first-hand experiences from industry experts
Learn more below or sign-up for this course directly
One module, different options
The best way to experience our modules is to follow the blended route. The online course acts as a prerquisite for the on-campus part.
This module scores 82%
Scholarship
Scholarships are available for our courses. Read more about current scholarships and how to apply.
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This 4-day on-campus course is held in beautiful Castle Oud Poelgeest near Leiden in the Netherlands. Participants who have successfully completed the online course are eligible for the on-campus course. Note that registration for the on-campus course includes the online course.
During the on-campus course, you will work in small groups on teaching cases based on real-world R&D projects. You will also meet peers and contributors from academia and leading life-sciences companies.
What makes this course special?
The on-campus course builds upon the principles of Questions Based Clinical Development (QBCD) that you learned in the online course. Preparation for the on-campus course involves approximately 20-30 hours studying the advanced teaching cases and completing individual pre-course assignments. You will then be prepared for the on-campus course in which you will work in small groups on assignments related to the teaching cases. As the “development team”, you and your group will make informed choices as you develop the product described in the teaching case. You will also present your proposal to a mock development board and/or regulatory agency representatives. Importantly, the teaching cases are based on real-world R&D projects and were developed in close collaboration with many who were actually involved in the original projects. Representatives from these companies will join us on campus to share their experiences and explain what really happened. Each year, a maximum of 25 participants are accepted to the on-campus course, ensuring a rich learning environment with highly focused discussions.
What will you learn?
During this intensive 4-day course, you will dive head-first into a number of advanced teaching cases. Each day, you will discuss either two
5 things you will take away from this course
During this course, you will:
- Experience the challenge of decision making on R&D projects
- Learn from the successes and failures of real-world R&D projects;
- Work in small, highly interactive interdisciplinary groups;
- Hear about first-hand experiences from industry experts.
This course receives a 9.5 from participants
Address
Kasteel Oud Poelgeest B.V., Poelgeesterweg, Oegstgeest, NetherlandsView on Google Maps
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Clinical Product Development contributors
On-campus
Nacer Lounis
Senior Principal Scientist
Janssen Pharmaceutica
On-campus
Tine de Marez
Senior Director, Compound Development Team Leader TB
Johnson & Johnson
On-campus
Erik Niks
Neurologist - Pediatric neurologist
Leiden University Medical Center
On-campus
Piet Hinoul
Chief Medical Officer
Virtual Incision
On-campus
Ad Sitsen
Owner
ClinPharMed Consultancy for Drug Development
Paul Stoffels
CEO
Galapagos
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
André Elferink
Clinical epidemiologist
Dutch Medicines Evaluation Board
Hans-Georg Eichler
Senior Medical Officer
European Medicines Agency
Inge de Lepeleire
Director Translational Pharmacology
MSD Europe
Johan Garssen
Director Immunology Platform
Danone/Nutricia Research
Rick Kuntz
Former Senior Vice President and Chief Scientific, Clinical and Regulatory Officer
Medtronic
Oliver Bisazza
Former Director Regulatory Policy
Medtronic
Richard Shull
Head of Deal Structuring and Trading Fundamentals
Shell
Pierre Peeters
Early Clinical Development Expert
Curare Consulting