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 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

Included in this course

Online exam
5-week Online course
4 days On-campus

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

Select your online course start date:

3,600

Apply

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

Videocall 120 Mar 2021
8:00 pm (GMT +1)
9:00 pm (GMT +1)

On-campus start date08 Jun 2021

On-campus extended start14 Jun 2021

Course length4 days

Study load20-30 hours

Course director

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
  • successful completion of the Clinical Development Online course
  • 20-30 hours of preparation time before the course
  • dedicated presence during 4 days in Leiden, the Netherlands
Scholarships are available for selected courses. Read more about current grant and scholarship opportunities here.

Clinical Development contributors

Clinical Development On-campus

Marc Martens

Head of Bird & Bird's Regulatory, Public & Administrative Law group in Brussels


Bird & Bird

Clinical Development On-campus

Aliki Nichogiannopoulou

Director


European Patent Office

Clinical Development On-campus

Bruno Vandermeulen

IP Lawyer - Member of the Brussels Bar


Independent IP practitioner

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

Clinical Development On-campus

Bert Leufkens

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


Utrecht Institute for Pharmaceutical Sciences (UIPS)

Clinical Development On-campus

Henk Schuring

VP-Head Rare Nephrology


Sanofi Genzyme

Clinical Development On-campus

Sjaak Bot

VP, Head of EMEA Regulatory Affairs


Janssen

Clinical Development On-campus

Bernd van der Meulen

Professor of Comparative Food Law


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

Clinical Development On-campus

Frank Landolt

Chief Counsel Legal & Intellectual Property


Confo Therapeutics

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

Eline Bunnik

Assistant professor Medical Ethics and Philosophy of Medicine


Erasmus MC

Clinical Development On-campus

Maurits Westerik

IE/IT lawyer


Coupry

Clinical Development On-campus

Bart Swinkels

Partner


NLO

Clinical Development On-campus

Karin Verzijden

Food and Pharma Lawyer


Axon Lawyers

On-campus

Clinical Development On-campus

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development


Paul Janssen Futurelab & Eagle Pharma Consult

Clinical Development On-campus

Kees Recourt

Investment Manager


Mibiton Foundation

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

On-campus

Clinical Development On-campus

Barbara J. van Zwieten-Boot

Vice Chair


Medicines Evaluation Board, The Netherlands

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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