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?

The on-campus course further builds on the principles of Questions Based Clinical Development (QBCD) that are introduced in the online course. On-campus, you will work in focus groups on advanced teaching cases. You are the development team. Which choices will you make to develop your product? Present and discuss your proposals with development boards and/or regulatory agency representatives. The teaching cases are developed in close collaboration with leading life sciences companies and institutes actually involved and are based on real R&D projects. Contributors from these companies and institutes join us on campus and share their experiences and explain what really happened at the end of each case study. A maximum of 25 participants are accepted to this course annually. A limited group size ensures a richer experience for participants and more focused discussions and group work.

What will you learn?

During an intensive 4-day course, you will dive head first into a myriad of advanced teaching cases. Every day 2 smaller cases or 1 large case are discussed. You will apply QBCD to different types of R&D projects (medicines, medical devices, medicinal foods) with information from publicly available and confidential sources (publications, case descriptions, video material, Investigator’s Brochures and other materials). The teaching cases are updated yearly and new cases are added to the program regularly. You will work on assignments and present your findings to “the board” and your fellow participants. Each session is closed with a plenary session where we discuss each other’s approaches and we hear from contributors in the “What really happened?” session. After completing this course, you will receive a certificate and you can continue to the on-campus extended course to develop your own idea into a clinical trial proposal.

5 things you will take away from this course

  1. deep understanding of how QBCD is applied
  2. learn from the successes and failures of real R&D projects
  3. work in small, interdisciplinary focus groups
  4. hear first-hand experiences from contributors from leading life sciences companies and institutes
  5. network with peers and contributors from related fields
This course receives a 9.5 from participants

This course receives a 9.5 from participants

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Included in this course

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

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

3,600

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Program information

Course length4 days

Study load20-30 hours

Course director

Adam Cohen

CEO 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
  • 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

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

V.P. intellectual property and legal


Ablynx N.V.

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

Senior Counsel


Bird & Bird

Clinical Development On-campus

Andrea Kamage

Patent Group Leader


Johnson & Johnson

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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