Clinical Development

Question Based Clinical Development facilitates the design of a rational and efficient development pathway for new medical interventions. Learn the principles behind QBCD and how to apply it to real R&D projects.

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Clinical Development Online

standalone or part of the blended course package

Want to have a look at the way we teach online?

Learn how to use the QBCD approach to formulate key questions when developing a new medical intervention

Learn how to deal optimally with development risks and costs

Learn how to work with the QBCD software program

Discuss online with peers and receive feedback from your course instructor

€ 1,600

Non-profit 25% discount

Select

Clinical 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

€ 3,600

Non-profit 25% discount

Select

Clinical Development
On-campus
Extended

prerequisite: online course and on-campus

Everything from

Online & On-campus +

Learn how to apply the QBCD approach on your own project

Learn how to turn an idea for a new intervention into a clinical trial application

Benefit from on our mentors’ vast expertise

Learn to present and discuss your idea with peers and experts

€ 5,600

Non-profit 25% discount

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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. After completing this intensive course, you may wish to dive even deeper into the clinical development process and take the on-campus extended course.

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 smaller cases or one large case, during which you will apply the QBCD approach to various types of R&D projects in various stages of development, using both publicly available information and privileged information such as publications, case descriptions, video material, and Investigator’s Brochures. Each year, the teaching cases are updated and new cases are added to the program. At the end of each session, you will participate in a plenary session where we discuss the approaches used by each team, and we will hear from those who were there in the “What really happened?” sessions. After completing this course, you will receive a certificate and will be eligible to take the on-campus extended course, where you can develop your own idea into a clinical trial proposal.

5 things you will take away from this course

During this course, you will:

  1. Experience the challenge of decision making on R&D projects
  2. Learn from the successes and failures of real-world R&D projects;
  3. Work in small, highly interactive interdisciplinary groups;
  4. Hear about first-hand experiences from industry experts.
This course receives a 9.5 from participants

This course receives a 9.5 from participants

Address

Kasteel Oud Poelgeest B.V., Poelgeesterweg, Oegstgeest, Netherlands
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I know enough, let's

Clinical Development contributors

On-campus

Clinical Development On-campus

Nacer Lounis

Senior Principal Scientist


Janssen Pharmaceutica

On-campus

Clinical Development On-campus

Tine de Marez

Senior Director, Compound Development Team Leader TB


Johnson & Johnson

On-campus

Clinical Development On-campus

Erik Niks

Neurologist - Pediatric neurologist


Leiden University Medical Center

On-campus

Clinical Development On-campus

Piet Hinoul

Global Head, Pre-Clinical, Clinical and Medical Affairs


J&J Ethicon

On-campus

Clinical Development On-campus

Ad Sitsen

Owner


ClinPharMed Consultancy for Drug Development

Clinical Development On-campus

Paul Stoffels

Chief scientific officer


Johnson & Johnson

Clinical Development On-campus

Tom Huizinga

Head of the Department of Rheumatology


Leiden University Medical Centre

On-campus

Clinical Development On-campus

Marcel Kenter

Director


Paul Janssen Futurelab Leiden

On-campus

Clinical Development On-campus

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery


Janssen Pharmaceutica NV

On-campus

Clinical Development 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

Clinical Development On-campus

Justin Hay

Pharmacokinetics Assessor


Medicines and Healthcare products Regulatory Agency

On-campus

Clinical Development On-campus

André Elferink

Clinical epidemiologist


Dutch Medicines Evaluation Board

On-campus

Clinical Development On-campus

Rob Zuiker

Senior Clinical Scientist


CHDR

Clinical Development On-campus

Hans-Georg Eichler

Senior Medical Officer


European Medicines Agency

On-campus

Clinical Development On-campus

Robert Klautz

Thoracic Surgeon


Leiden University Medical Centre

On-campus

Clinical Development On-campus

Matthijs Moerland

Research Director Translational Biomarkers


CHDR

Clinical Development On-campus

Joris Rotmans, MD, PhD

internist-nephrologist


LUMC

On-campus

Clinical Development On-campus

Janneke Meulenberg

CEO


Arthrogen

Clinical Development On-campus

Inge de Lepeleire

Director Translational Pharmacology


MSD Europe

On-campus

Clinical Development On-campus

Koos Burggraaf

Research Director CVS & Metabolism


CHDR

Clinical Development On-campus

Johan Garssen

Director Immunology Platform


Danone/Nutricia Research

On-campus

Clinical Development On-campus

Ingrid de Visser

Senior Clinical Scientist


CHDR

Clinical Development On-campus

Rick Kuntz

Senior Vice President and Chief Scientific, Clinical and Regulatory Officer


Medtronic

On-campus

Clinical Development On-campus

Geert Jan Groeneveld

Research Director CNS


CHDR

Clinical Development On-campus

Oliver Bisazza

Director Regulatory Policy


Medtronic

Clinical Development On-campus

Saco de Visser

Teacher and Clinical Pharmacologist


Paul Janssen Futurelab Leiden

On-campus

Clinical Development On-campus

Adam Cohen

CEO and clinical pharmacologist


Centre for Human Drug Research

Clinical Development On-campus

Richard Shull

Head of Deal Structuring and Trading Fundamentals


Shell

Clinical Development On-campus

Pierre Peeters

Former site head early stage development


Organon

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