Module

Biomedical Science

Pharmacology Online

In this five-week online Futurelab course, you are introduced to the modern, key pharmacological concepts. These key pharmacological concepts are reviewed in light of their role in medicinal product development and are linked to five key questions that need to be answered during the development process of a novel medical intervention. During this course, you will also learn how to use and apply a specific tool which helps you to make a synthesis and a graphical display of (non-)clinical research data available in Investigator’s Brochures which will guide you in the development process.

In this online course, a variety of exercises will help you master the (non-)clinical research data tool and use the five key questions for practical scenarios based on real-world case studies. In addition, the online course uses a wide variety of teaching methods, including animations, tutorials, scientific articles, interviews with industry experts and authorities, Futurelab Talks, self-assessment tools, quizzes, assignments, online discussions with fellow course participants, and feedback from Futurelab experts.

Online, for your convenience

Each week of the course starts by an introductory, real-world case, highlighting the importance and dilemmas of that week’s topic in medicinal product development.  The main topics per week are:

Week 1. Does the product cause its intended pharmacological/functional effect(s)?
Covering pharmacodynamics, target-product interactions, signalling pathways and available methods to address this question in medicinal product development.

Week 2. Does the biologically active product/active metabolites get to the site of action?
Covering administration routes, Absorption, Distribution, Metabolism, Elimination, Volume of distribution, medicinal product regimens and available methods to address this question in medicinal product development.

Week 3. Does the product have beneficial effects on the disease or its pathophysiology?
Covering signalling to disease intervention, pharmacology of the main interventions for a collection of major disease states and available methodology to address this question in medicinal product development.

Week 4. What is the therapeutic window of the new medicinal product?
Covering mechanisms of Adverse Reactions, finding the right clinical starting dose from non-clinical experiments using the (non-)clinical research data tool, and available methods to address this question in medicinal product development.

Week 5. How do the sources of variability in medicinal product response in the target population affect the development of the product?
Covering pharmacology in special populations (eg paediatrics, geriatrics, pregnancy etc), product-product interactions, pharmacogenetics, defining Target Product Profile (implications for development) and available methods to address this question in medicinal product development

Study time

You will be expected to spend approximately 5 hours per week for five consecutive weeks.

Online exam

Your understanding of the course material will be assessed by an online exam. You will need access to a computer with webcam, a stable internet connection, a clean desk, and a private room. Participants will be monitored by a professional invigilator via webcam during the exam. After passing the exam, you will obtain a Paul Janssen Futurelab certificate and will be eligible to apply for the on-campus Pharmacology course.

Learning outcomes

Upon completion of this online course, you will have a clear understanding of basic pharmacology in relation to the mechanism of action of the medicinal product under development. Specifically, you will be able to:

  1. Understand basic pharmacological principles and its implications for medicinal product development;
  2. Understand basic pharmacokinetic principles and its implications for medicinal product development;
  3. Understand how pharmacological action affects disease pathophysiology for major disease states;
  4. Understand how the therapeutic window is determined for novel pharmacological interventions;
  5. Understand how to define the Target Product Profile and how this affects medicinal product development.

Requirements

  • A master’s degree in any subject related to biomedical science;
  • Several years of relevant working experience.

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Your teacher

Saco de Visser

Head of Education and Clinical Pharmacologist

Biomedical Science contributors

Pharmacology Online

Erik Niks MD PhD

Neurologist - Pediatric neurologist
Leiden University Medical Center

Pharmacology Online

Piet Hinoul

Global Head, Pre-Clinical, Clinical and Medical Affairs
J&J Ethicon

Pharmacology Online

Prof. Ad Sitsen MD PhD

Owner
ClinPharMed Consultancy for Drug Development

Pharmacology Online

Wim Parys

Head of R&D Global Public Health
Janssen Pharmaceutica

Pharmacology Online

Eline Bunnik

Assistant professor Medical Ethics and Philosophy of Medicine
Erasmus MC

Pharmacology Online

Maurits Westerik

Senior Counsel
Bird & Bird

Pharmacology Online

Andrea Kamage

Patent Group Leader
Johnson & Johnson

Pharmacology Online

Bart Swinkels

Partner
NLO

Pharmacology Online

Karin Verzijden

Food and Pharma Lawyer
Axon Lawyers

Pharmacology Online

Ineke Jonker-Hoogerkamp

Consultant Regulatory Affairs and Drug Development
Eagle Pharma Consult

Pharmacology Online

Kees Recourt

Investment Manager
Mibiton Foundation

Pharmacology Online

Paul Stoffels

Chief scientific officer
Johnson & Johnson

Pharmacology Online

Tom Huizinga

Head of the Department of Rheumatology
Leiden University Medical Centre

Pharmacology Online

Marcel Kenter

Director
Paul Janssen Futurelab Leiden

Pharmacology Online

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery
Janssen Pharmaceutica NV

Pharmacology Online

Andreas Wallnöfer

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

Pharmacology Online

Justin Hay

Pharmacokinetics Assessor
Medicines and Healthcare products Regulatory Agency

Pharmacology Online

André Elferink

Clinical epidemiologist
Dutch Medicines Evaluation Board

Pharmacology Online

Rob Zuiker

Senior Clinical Scientist
CHDR

Pharmacology Online

Barbara J. van Zwieten-Boot

Vice Chair
Medicines Evaluation Board, The Netherlands

Pharmacology Online

Hans-Georg Eichler

Senior Medical Officer
European Medicines Agency

Pharmacology Online

Robert Klautz

Thoracic Surgeon
Leiden University Medical Centre

Pharmacology Online

Matthijs Moerland

Research Director Translational Biomarkers
CHDR

Pharmacology Online

Joris Rotmans, MD, PhD

internist-nephrologist
LUMC

Pharmacology Online

Janneke Meulenberg

CEO
Arthrogen

Pharmacology Online

Inge de Lepeleire

Director Translational Pharmacology
MSD Europe

Pharmacology Online

Koos Burggraaf

Research Director CVS & Metabolism
CHDR

Pharmacology Online

Johan Garssen

Director Immunology Platform
Danone/Nutricia Research

Pharmacology Online

Ingrid de Visser

Senior Clinical Scientist
CHDR

Pharmacology Online

Rick Kuntz

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

Pharmacology Online

Geert Jan Groeneveld

Research Director CNS
CHDR

Pharmacology Online

Oliver Bisazza

Director Regulatory Policy
Medtronic

Pharmacology Online

Saco de Visser

Head of Education and Clinical Pharmacologist
Paul Janssen Futurelab Leiden

Pharmacology Online

Adam Cohen

CEO and clinical pharmacologist
Centre for Human Drug Research

Pharmacology Online

Richard Shull

Head of Deal Structuring and Trading Fundamentals
Shell

Pharmacology Online

Pierre Peeters

Former site head early stage development
Organon

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