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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.
Course content
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 while taking the course. 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:
- Understand basic pharmacological principles and its implications for medicinal product development;
- Understand basic pharmacokinetic principles and its implications for medicinal product development;
- Understand how pharmacological action affects disease pathophysiology for major disease states;
- Understand how the therapeutic window is determined for novel pharmacological interventions;
- 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.
As you have noticed this learning environment is pretty straightforward. Although we take great care to ensure the learning environment works on all browsers, Explorer may give suboptimal results (especially in video quality). Chrome, Safari or Firefox are recommended.
You can go back and forth in the course using the
buttons in the blue header of this learning environment. The next button is only active if all assignments of the topic are completed. The 
button in the header allows you to view the available course content at any time including reference to the topics you have already covered. At the bottom of each screen, you will find a 
button which enables you to ask for help -either with technical issues or course content related. You will be joined by other online course participants allowing you at specified times to interact and learn from each other. Use the 
button in the footer if you want to exit the learning environment.
During the course, you will at times be prompted to answer some self-assessment questions, perform and upload assignments and/or engage in online discussion by reflecting on your fellow learners assignment results. The scores of the self-assessments are not recorded. The self-assessments are included in this course for you conveniences to test if you comprehend the presented course content.
All videos in this course can be viewed with English subtitles. Press the CC button 
in the videoplayer to acces them. Some videos provide to option to naigate between chapters. Press this button 
to open the menu with all chapters. You will see each chapter marked as a dot on the videotimeline too.
Feel free to contact us by using the button in case you run into either technical problems or have course content related questions or issues.
This demo includes the course outline and several topics. Please have a look to see our learning platform and the way we like to teach online.
Activity
In the full course, you will see messages from your course instructor, uploaded assignments and comments from your fellow course participants.