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 blended course consists of an online course and 2 on-campus courses. Have the flexibility to learn online from anywhere and at your own pace in the online course. Then join the advanced on-campus course in Leiden, the Netherlands, to widen your network, work on real-world teaching cases and meet peers and contributors from academia and leading life sciences companies. Jumpstart your next project in the on-campus extended course and take advantage of the expertise of experienced mentors to write a clear clinical trial protocol that is ready to submit to authorities and funders.

What makes this course special?

This online course is the first of 3 parts of the blended course. You are introduced to Question Based Clinical Development (QBCD): an approach that facilitates the rational and efficient design of a developmental pathway for new medical interventions. The concept is derived from Real Options Theory which is commonly used in oil industry, an industry that deals with similar high uncertainties and costs, as does clinical development. Adapted to the clinical field, QBCD offers significant advantages compared to the commonly used NPV assessment and is aimed to optimize project values by identifying and addressing the critical development questions to streamline development projects. The QBCD approach has recently been published in Nature Biotechnology. You can read and/or download the article via this link. If you have problems downloading it, please contact the office.

What will you learn?

In 5 weeks, you will learn the basic principles of QBCD and how to apply it to teaching cases that are based on real R&D projects. Using the principles, you will be able to identify the most important questions that need to be answered during the developmental process of any medical R&D project, be it medicines, medical devices or medicinal foods. Examples from each of these areas are included in the course. The online course gives you the flexibility to learn from anywhere at your own pace and offers guidance from a course teacher. Your course teacher actively takes part in the discussions and gives feedback on assignments during the course.  The course is completed with an online exam. Participants who complete the online course will receive a certificate and are eligible to apply for the on-campus and on-campus extended courses.

4 things you will take away from this course

  1. formulate key questions for the development of new medical interventions using QBCD
  2. learn how to optimally deal with risk and costs
  3. learn from the successes and failures of previous R&D projects
  4. discuss with peers from around the world and receive feedback from your course teacher
This course receives a 9 from participants

This course receives a 9 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:

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Program information

Online course starts04 May 2020

On-campus start date21 Sep 2020

On-campus extended start25 Sep 2020

Course length5 weeks

Study load5 hours a week

Your teacher

Saco de Visser

Teacher and Clinical Pharmacologist

Requirements

  • at least a master's degree in a subject related to (bio)medical science
  • a few years of relevant working experience
  • 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

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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