Clinical Product Development
Clinical development is crucial part of R&D for new products. Enhance your skills in selecting safe and informative starting doses using NOAEL and MABEL methods, and gain insight in project valuation calculations through case studies based on real-world R&D projects.
Subscribe now or read more about this module below
Signup for 27 Oct 2025
Download the Clinical Product Development brochure
Download brochure
Clinical Product Development Online
Clinical product development is a vital phase in bringing new products to the market and patients. Learn from inspiring real-world case studies.
Want to have a look at the way we teach online?
Gain insights into the challenges of product development spanning from discovery, (non-)clinical development and market approval.
Learn the roles and responsibilities of Principle Investigators (PIs), Sponsors, Institutional Board of Directors, DSMCs, IECs/IRBs, Clinical Trial Authorities and other stakeholders.
Gain the skills to determine a safe starting dose for a First-in-Human Trial using the NOAEL or MABEL method.
Develop critical reading skills by analyzing a real-world Investigator’s Brochure for a First-in-Human trial.
Clinical Product Development On-campus
prerequisite: online course
Everything from
Online +
Experience the challenge of decision making on R&D projects
Learn from the successes and failures of real-world R&D projects
Learn from your group members in small, interdisciplinary working groups
Hear about first-hand experiences from industry experts
Learn more below or sign-up for this course directly
One module, different options
The best way to experience our modules is to follow the blended route. The online course acts as a prerquisite for the on-campus part.
This module scores 82%
Scholarship
Scholarships are available for our courses. Read more about current scholarships and how to apply.
Read more
Real-life examples
The course was based on real-life examples that covered all aspects of clinical product development.
Paul Noordhuis, PhD. Principal scientist, J&J Innovative Medicine
Clinical Product Development Online graduate
Fun deep dive
It is a fun deep dive into the complete image of clinical product development.
Simone Hermans, PhD. Health Holland
Clinical Product Development Online Graduate
Practical knowledge, a must-attend
This course excelled in delivering practical IP knowledge focused on biotechnology. A must-attend for anyone interested in biotech IP.
Joke van Bemmel, Ass. Director, R&D Strategic Initiative, Genmab
Intellectual Property Online graduate
Company perspective
I have systemically learned clinical product development from the company perspective, instead of sticking to my academic mindset.
Canxi Shi, Phd, Erasmus MC
Clinical Product Development Online graduate
We understand if you want to have a look at this course. Login or create an account to access a free demo of the online course.
A confirmation email will be sent to new registrations. After completion, you're able to acces the online demo.
This online course can be taken as a stand-alone course or as part of the blended learning-by-doing course Clinical Product Development, giving you the freedom to learn online in a time and place independent fashion from anywhere where you have internet access. At the end of the online course you will take a short online exam; participants who pass the exam will receive a certificate of completion and are eligible for the on-campus course held in the beautiful Castle Oud Poelgeest near Leiden in the Netherlands.
What makes this course special?
The online course offers a hands-on approach to tackling clinical product development challenges through real-world case studies and interviews with regulators, as well as Chief Scientific and Medical Officers from top pharmaceutical and medical device companies.
The course emphasizes learning by doing, featuring interactive elements such as quizzes, polls, self-assignments, animations, and the Netflix-style series QUESTIONS! that demonstrates the application of Real Option-based project valuation techniques.
The online course is designed to be flexible, allowing you to study at your own pace and schedule your learning hours based on your personal availability.
The course ends with an online exam to reinforce your understanding.
What will you learn?
The course begins with an introduction to the role of regulatory guidelines in medicinal product development, led by Principal Investigators and industry professionals. It features exercises focused on the discovery (non-)clinical development, and market approval of a novel antibiotic with a unique mechanism of action.
You will then explore key documents for a Clinical Trial Application (CTA), including the Clinical Research Protocol, Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD), Patient Information Sheet (PIS), and Informed Consent Form (ICF).
You will be introduced into project valuation methods such as risk-adjusted Net Present Value (NPV) and Real Option Analysis (ROA). Using two real-world case studies, you will prioritize clinical development questions, draft development plans, and review the outcomes of developing a medical device and medical nutrition.
You’ll also learn to determine a safe starting dose for a First-in-Human (FiH) trial using NOAEL and MABEL approaches.
5 things you will take away from this course
During this course, you will:
- Gain insights into the challenges of product development, spanning discovery, (non-)clinical development, and market approval.
- Master project valuation methodologies for clinical development, including risk-adjusted NPV and Real Options Analysis using scientific questions.
- Understand the roles and responsibilities of Principal Investigators (PIs), Sponsors, Institutional Boards of Directors, DSMCs, IECs/IRBs, Clinical Trial Authorities, and other key stakeholders.
- Develop critical reading skills by analyzing a real-world Investigator’s Brochure (IB) for a First-in-Human trial.
- Gain the skills to determine a safe and informative starting dose for a First-in-Human trial using the NOAEL or MABEL method, and learn how to choose the appropriate approach for your product’s clinical development.
Article in Nature Biotechnology
In January 2020 we published the article Integrating scientific considerations into R&D project valuation in the prestigious journal Nature Biotechnology describing project valuation using a Real Option-based approach. you can download the article (if you experience problems downloading the file, please contact us).
I know enough, let's