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.

Signup for 01 Mar 2021

Or read more about this module below

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

Select

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%

Module thumbnail

We understand if you want to have a look at this course. Login or create an account to access a free demo of the online course.

A confirmation email will be sent to new registrations. After completion, you're able to acces the online demo.

This online course can be taken as a stand-alone course or as part of the blended learning-by-doing course Clinical Development, giving you the freedom to learn online in a time and place independent fashion from anywhere where you have internet access. At the end of the online course you will take a short online exam; participants who pass the exam will receive a certificate of completion and are eligible for the on-campus course held in the beautiful Castle Oud Poelgeest near Leiden in the Netherlands.

What makes this course special?

This online course is the first part of our three-part blended course that also includes on-campus and on-campus extended parts. In the online course, you will be introduced to Question-Based Clinical Development (QBCD), an innovative approach to designing a rational and efficient pathway for developing new medical interventions. The QBCD concept is derived from Real Options Theory, which is commonly used by the oil industry to deal with the high levels of uncertainty and large investments that are also common to clinical development. Adapted to the biomedical industry, QBCD offers significant advantages compared to the commonly used net present value (NPV) and risk-adjusted project value calculations. Specifically, the goal of QBCD is to optimize project value by identifying and addressing critical questions early, thereby streamlining the development of new medical interventions.

What will you learn?

In this 5-week course, you will learn the basic principles of QBCD and how to apply this approach to teaching cases based on real-world R&D projects. Using these principles and clear examples, you will learn to identify the key questions that must be answered when developing new medical interventions such as medicinal

products, vaccines, advanced therapy medicinal products, medical devices, and medicinal foods. During the online course, you will receive close guidance from the course instructor, who will actively participate in discussions and give valuable feedback on assignments.

4 things you will take away from this course

During this course, you will:

  1. Learn how to use the QBCD approach to formulate key questions when developing a new medical intervention;
  2. Learn how to deal optimally with development risks and costs;
  3. Learn how to work with the QBCD software program; and
  4. Engage in online discussions with your peers and receive feedback from your course instructor.

Article in Nature Biotechnology

We recently published the QBCD approach in the prestigious journal Nature Biotechnology; you can download the article (if you experience problems downloading the file, please contact us).

I know enough, let's

Clinical Development contributors

On-campus

Clinical Development Online

Nacer Lounis

Senior Principal Scientist


Janssen Pharmaceutica

On-campus

Clinical Development Online

Tine de Marez

Senior Director, Compound Development Team Leader TB


Johnson & Johnson

On-campus

Clinical Development Online

Erik Niks

Neurologist - Pediatric neurologist


Leiden University Medical Center

On-campus

Clinical Development Online

Piet Hinoul

Global Head, Pre-Clinical, Clinical and Medical Affairs


J&J Ethicon

On-campus

Clinical Development Online

Ad Sitsen

Owner


ClinPharMed Consultancy for Drug Development

Clinical Development Online

Paul Stoffels

Chief scientific officer


Johnson & Johnson

Clinical Development Online

Tom Huizinga

Head of the Department of Rheumatology


Leiden University Medical Centre

On-campus

Clinical Development Online

Marcel Kenter

Director


Paul Janssen Futurelab Leiden

On-campus

Clinical Development Online

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery


Janssen Pharmaceutica NV

On-campus

Clinical Development Online

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 Online

Justin Hay

Pharmacokinetics Assessor


Medicines and Healthcare products Regulatory Agency

On-campus

Clinical Development Online

André Elferink

Clinical epidemiologist


Dutch Medicines Evaluation Board

On-campus

Clinical Development Online

Rob Zuiker

Senior Clinical Scientist


CHDR

On-campus

Clinical Development Online

Barbara J. van Zwieten-Boot

Vice Chair


Medicines Evaluation Board, The Netherlands

Clinical Development Online

Hans-Georg Eichler

Senior Medical Officer


European Medicines Agency

On-campus

Clinical Development Online

Robert Klautz

Thoracic Surgeon


Leiden University Medical Centre

On-campus

Clinical Development Online

Matthijs Moerland

Research Director Translational Biomarkers


CHDR

Clinical Development Online

Joris Rotmans, MD, PhD

internist-nephrologist


LUMC

On-campus

Clinical Development Online

Janneke Meulenberg

CEO


Arthrogen

Clinical Development Online

Inge de Lepeleire

Director Translational Pharmacology


MSD Europe

On-campus

Clinical Development Online

Koos Burggraaf

Research Director CVS & Metabolism


CHDR

Clinical Development Online

Johan Garssen

Director Immunology Platform


Danone/Nutricia Research

On-campus

Clinical Development Online

Ingrid de Visser

Senior Clinical Scientist


CHDR

Clinical Development Online

Rick Kuntz

Senior Vice President and Chief Scientific, Clinical and Regulatory Officer


Medtronic

On-campus

Clinical Development Online

Paul de Koning

Exploratory Development Expert


Former Head Clinical Pharmacology & Exploratory Development Astellas

On-campus

Clinical Development Online

Geert Jan Groeneveld

Research Director CNS


CHDR

Clinical Development Online

Oliver Bisazza

Director Regulatory Policy


Medtronic

Clinical Development Online

Saco de Visser

Teacher and Clinical Pharmacologist


Paul Janssen Futurelab Leiden

On-campus

Clinical Development Online

Adam Cohen

CEO and clinical pharmacologist


Centre for Human Drug Research

Clinical Development Online

Richard Shull

Head of Deal Structuring and Trading Fundamentals


Shell

Clinical Development Online

Pierre Peeters

Former site head early stage development


Organon

Stay updated about this course