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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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.

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

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.

This course receives a 8.2 from participants

Included in this course

5-week Online course
Online exam

We offer a 25% discount to non-profit organizations. Select your option and select your start date:

Clear

Program information

Deadline registration online course06 Sep 2020

Online course starts07 Sep 2020

Online exam option 127 Oct 2020

Online exam option 205 Nov 2020

On-campus start date08 Jun 2021

On-campus extended start14 Jun 2021

Course length5 weeks

Study load5 hours a week

Program information

Deadline registration online course28 Feb 2021

Online course starts01 Mar 2021

Online exam option 113 Apr 2021

Online exam option 222 Apr 2021

On-campus start date08 Jun 2021

On-campus extended start14 Jun 2021

Course length5 weeks

Study load5 hours a week

Your teacher

Saco de Visser

Requirements

  • at least a master's degree in a subject related to (bio)medical science
  • a few years of relevant working experience
  • basic understanding of clinical trial designs’
  • no previous experience with QBCD is required
Scholarships are available for selected courses. Scholarships do not include travel and lodging costs. Read more about current grant and scholarship opportunities here.

Clinical Development contributors

Clinical Development Online

Bruno Vandermeulen

IP Lawyer - Member of the Brussels Bar


Independent IP practitioner

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

Clinical Development Online

Bert Leufkens

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


Utrecht Institute for Pharmaceutical Sciences (UIPS)

Clinical Development Online

Henk Schuring

VP-Head Rare Nephrology


Sanofi Genzyme

Clinical Development Online

Sjaak Bot

VP, Head of EMEA Regulatory Affairs


Janssen

Clinical Development Online

Bernd van der Meulen

Professor of Comparative Food Law


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

Clinical Development Online

Frank Landolt

V.P. intellectual property and legal


Ablynx N.V.

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

Eline Bunnik

Assistant professor Medical Ethics and Philosophy of Medicine


Erasmus MC

Clinical Development Online

Maurits Westerik

Senior Counsel


Bird & Bird

Clinical Development Online

Andrea Kamage

Patent Group Leader


Johnson & Johnson

Clinical Development Online

Bart Swinkels

Partner


NLO

Clinical Development Online

Karin Verzijden

Food and Pharma Lawyer


Axon Lawyers

On-campus

Clinical Development Online

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development


Paul Janssen Futurelab & Eagle Pharma Consult

Clinical Development Online

Kees Recourt

Investment Manager


Mibiton Foundation

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

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

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