Module

Clinical Development

The Clinical Development program at Paul Janssen Futurelab Leiden provides “learning-by-doing” training to ambitious postgraduate biomedical researchers who wish to further their career and increase their knowledge on the development of novel medical interventions. The program focuses on several important aspects associated with the development medicinal products, medical devices, and medical nutrition products. The Clinical Development program consists of three sequential courses:

Clinical Development On-campus Extended

This 5-day On-campus Extended Futurelab course follows from the 4-day On-campus. In this course, you will work with a mentor (a clinical expert) to develop your own clinical trial based on the brief pre-proposal that you submitted with your application. In addition, your mentor will guide you through the scientific and practical challenges associated with drafting a clinical trial application, this course takes place in Leiden, the Netherlands.

Learning outcomes

Upon completing this course, you will be able to take a preliminary idea for a novel medical intervention and turn it into a fully developed clinical trial protocol. In addition, you will have a clear understanding of what constitutes a complete research file ready to be submitted to the appropriate authorities and research ethics committees.

Application procedure for this course

The number of spaces is limited. Therefore, applicants will be selected based on their application for the On-campus course, as well as their pre-proposal for the clinical trial to be developed during On-campus Extended. Note that participants for this course must first successfully complete both the Online course and the On-campus course.

€500,000 grant for the best clinical trial application

A highly competitive €500,000 grant from the Dutch funding agency ZonMw is available for the best clinical trial application developed during this course, for testing a registered medicinal product in a Dutch research institute or hospital. Paul Janssen Futurelab Leiden will review all developed clinical trial applications during this course and award the best proposal with a nomination letter that can be used for obtaining the ZonMw grant.

Requirements

  • successful application for this course
  • successful completion of the Clinical Development Online course
  • a Good Clinical Practice certificate (or equivalent) within four years of applying for this course

Address

Included in this course

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

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

Select your online course start date:

5,600

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Program information

Online course starts05 Mar 2018

Online exam26 Apr 2018

On-campus start dateJune 2018

Course length5 day

Course director

Adam Cohen

CEO and clinical pharmacologist

Clinical Development contributors

Clinical Development On-campus Extended

Paul Stoffels

Chief scientific officer
Johnson & Johnson

Clinical Development On-campus Extended

Tom Huizinga

Head of the Department of Rheumatology
Leiden University Medical Centre

Clinical Development On-campus Extended

Marcel Kenter

Director
Paul Janssen Futurelab Leiden

Clinical Development On-campus Extended

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery
Janssen Pharmaceutica NV

Clinical Development On-campus Extended

Andreas Wallnöfer

General Partner
BioMed Partners Venture Capital (former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd.)

Clinical Development On-campus Extended

Justin Hay

Pharmacokinetics Assessor
Medicines and Healthcare products Regulatory Agency

Clinical Development On-campus Extended

André Elferink

Clinical epidemiologist
Dutch Medicines Evaluation Board

Clinical Development On-campus Extended

Rob Zuiker

Senior Clinical Scientist
CHDR

Clinical Development On-campus Extended

Barbara J. van Zwieten-Boot

Vice Chair
Medicines Evaluation Board, The Netherlands

Clinical Development On-campus Extended

Hans-Georg Eichler

Senior Medical Officer
European Medicines Agency

Clinical Development On-campus Extended

Robert Klautz

Thoracic Surgeon
Leiden University Medical Centre

Clinical Development On-campus Extended

Matthijs Moerland

Research Director Translational Biomarkers
CHDR

Clinical Development On-campus Extended

Joris Rotmans, MD, PhD

internist-nephrologist
LUMC

Clinical Development On-campus Extended

Janneke Meulenberg

CEO
Arthrogen

Clinical Development On-campus Extended

Inge de Lepeleire

Director Translational Pharmacology
MSD Europe

Clinical Development On-campus Extended

Koos Burggraaf

Research Director CVS & Metabolism
CHDR

Clinical Development On-campus Extended

Johan Garssen

Director Immunology Platform
Danone/Nutricia Research

Clinical Development On-campus Extended

Ingrid de Visser

Senior Clinical Scientist
CHDR

Clinical Development On-campus Extended

Rick Kuntz

Senior Vice President and Chief Scientific, Clinical and Regulatory Officer
Medtronic

Clinical Development On-campus Extended

Geert Jan Groeneveld

Research Director CNS
CHDR

Clinical Development On-campus Extended

Oliver Bisazza

Director Regulatory Policy
Medtronic

Clinical Development On-campus Extended

Saco de Visser

Head of Education and Clinical Pharmacologist
Paul Janssen Futurelab Leiden

Clinical Development On-campus Extended

Adam Cohen

CEO and clinical pharmacologist
Centre for Human Drug Research

Clinical Development On-campus Extended

Richard Shull

Head of Deal Structuring and Trading Fundamentals
Shell

Clinical Development On-campus Extended

Pierre Peeters

Former site head early stage development
Organon

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