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?

Writing a clear and concise proposal is essential to present clinical research to authorities and to obtain funding. This course in the form of a guided workshop [FM(1] allows participants to work out their own idea for a clinical study into a protocol that is ready for submission. Clinical experts from the Centre of Human Drug Research give feedback during the writing process. The Centre of Human Drug Research specializes in early-stage clinical drug research and has more than 3 decades of experience in designing and performing clinical studies. This course has a largely open structure and participants choose their own focus. A broad range of questions are tackled depending on the needs of participants, from content-related aspects to procedural hurdles. A maximum of 15 participants are accepted to this course annually to ensure the best learning experience for participants and focused guidance.

What will you learn?

As mentioned before, the format of this course is largely open. So, you decide where the course takes you. You will have the chance to think about your proposal before the course and to submit a short general outline with your registration. You are individually matched with a mentor based on your field and outlined proposal. During the course, you will expand on your outline and further incorporate the concepts learned during the on-campus course. As a framework, we offer general guidelines on how to write a clinical trial protocol. At the beginning and end of the day is a plenary session during which we discuss general questions. Each participant works individually on their dossier and has regular interaction with their mentor. At the end of each day, you submit your draft protocol to receive feedback from your mentor. All materials are of course treated confidentially. You will receive a certificate upon completion of the course. At the end of the 5-day course, you will have a strong base for your proposal. But the work does not end there! You may discover that you need to go back to your data and perhaps back into the lab to ready your proposal for submission. Going through this iterative process with your team will give you the strongest proposal for your project.

4 things you take away from this course

  1. apply QBCD on your own project
  2. learn how to turn a preliminary idea into a complete clinical trial proposal
  3. take advantage of the expertise of experienced mentors
  4. work alongside peers in the inspiring setting of Centre for Human Drug Research in Leiden Bioscience Park
This course receives a 8 from participants

This course receives an 8 from participants

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Included in this course

5 days On-campus Extended
4 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 starts02 Mar 2020

On-campus start date08 Jun 2020

On-campus extended start12 Jun 2020

Course length5 days

Course director

Adam Cohen

CEO and clinical pharmacologist

Requirements

  • a master's degree in a subject related to biomedical science
  • a few years of relevant working experience
  • successful completion of the Clinical Development Online and On-campus courses
  • submission of a brief general outline of your proposed study (template available)
  • dedicated presence during 5 days in Leiden, the Netherlands
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 On-campus Extended

Nacer Lounis

Senior Principal Scientist


Janssen Pharmaceutica

On-campus

Clinical Development On-campus Extended

Tine de Marez

Senior Director, Compound Development Team Leader TB


Johnson & Johnson

Clinical Development On-campus Extended

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 Extended

Henk Schuring

VP-Head Rare Nephrology


Sanofi Genzyme

Clinical Development On-campus Extended

Sjaak Bot

VP, Head of EMEA Regulatory Affairs


Janssen

Clinical Development On-campus Extended

Bernd van der Meulen

Professor of Comparative Food Law


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

Clinical Development On-campus Extended

Frank Landolt

V.P. intellectual property and legal


Ablynx N.V.

On-campus

Clinical Development On-campus Extended

Erik Niks

Neurologist - Pediatric neurologist


Leiden University Medical Center

On-campus

Clinical Development On-campus Extended

Piet Hinoul

Global Head, Pre-Clinical, Clinical and Medical Affairs


J&J Ethicon

On-campus

Clinical Development On-campus Extended

Ad Sitsen

Owner


ClinPharMed Consultancy for Drug Development

Clinical Development On-campus Extended

Eline Bunnik

Assistant professor Medical Ethics and Philosophy of Medicine


Erasmus MC

Clinical Development On-campus Extended

Maurits Westerik

Senior Counsel


Bird & Bird

Clinical Development On-campus Extended

Andrea Kamage

Patent Group Leader


Johnson & Johnson

Clinical Development On-campus Extended

Bart Swinkels

Partner


NLO

Clinical Development On-campus Extended

Karin Verzijden

Food and Pharma Lawyer


Axon Lawyers

On-campus

Clinical Development On-campus Extended

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development


Paul Janssen Futurelab & Eagle Pharma Consult

Clinical Development On-campus Extended

Kees Recourt

Investment Manager


Mibiton Foundation

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

On-campus

Clinical Development On-campus Extended

Marcel Kenter

Director


Paul Janssen Futurelab Leiden

On-campus

Clinical Development On-campus Extended

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery


Janssen Pharmaceutica NV

On-campus

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.)

On-campus

Clinical Development On-campus Extended

Justin Hay

Pharmacokinetics Assessor


Medicines and Healthcare products Regulatory Agency

On-campus

Clinical Development On-campus Extended

André Elferink

Clinical epidemiologist


Dutch Medicines Evaluation Board

On-campus

Clinical Development On-campus Extended

Rob Zuiker

Senior Clinical Scientist


CHDR

On-campus

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

On-campus

Clinical Development On-campus Extended

Robert Klautz

Thoracic Surgeon


Leiden University Medical Centre

On-campus

Clinical Development On-campus Extended

Matthijs Moerland

Research Director Translational Biomarkers


CHDR

Clinical Development On-campus Extended

Joris Rotmans, MD, PhD

internist-nephrologist


LUMC

On-campus

Clinical Development On-campus Extended

Janneke Meulenberg

CEO


Arthrogen

Clinical Development On-campus Extended

Inge de Lepeleire

Director Translational Pharmacology


MSD Europe

On-campus

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

On-campus

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

On-campus

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

On-campus

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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