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

Subscribe today

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.

€ 1,600

Non-profit 25% discount

Select

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

€ 3,600

Non-profit 25% discount

Select

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

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 4-day on-campus course is held in beautiful Castle Oud Poelgeest near Leiden in the Netherlands. Participants who have successfully completed the online course are eligible for the on-campus course. Note that registration for the on-campus course includes the online course.

During the on-campus course, you will work in small groups on teaching cases based on real-world R&D projects. You will also meet peers and contributors from academia and leading life-sciences companies.

What makes this course special?

The on-campus course builds upon the principles of Questions Based Clinical Development (QBCD) that you learned in the online course. Preparation for the on-campus course involves approximately 20-30 hours studying the advanced teaching cases and completing individual pre-course assignments. You will then be prepared for the on-campus course in which you will work in small groups on assignments related to the teaching cases. As the “development team”, you and your group will make informed choices as you develop the product described in the teaching case. You will also present your proposal to a mock development board and/or regulatory agency representatives. Importantly, the teaching cases are based on real-world R&D projects and were developed in close collaboration with many who were actually involved in the original projects. Representatives from these companies will join us on campus to share their experiences and explain what really happened. Each year, a maximum of 25 participants are accepted to the on-campus course, ensuring a rich learning environment with highly focused discussions.

What will you learn?

During this intensive 4-day course, you will dive head-first into a number of advanced teaching cases. Each day, you will discuss either two

smaller cases or one large case, during which you will apply the QBCD approach to various types of R&D projects in various stages of development, using both publicly available information and privileged information such as publications, case descriptions, video material, and Investigator’s Brochures. Each year, the teaching cases are updated and new cases are added to the program. At the end of each session, you will participate in a plenary session where we discuss the approaches used by each team, and we will hear from those who were there in the “What really happened?” sessions. After completing this course, you will receive a certificate.

5 things you will take away from this course

During this course, you will:

  1. Experience the challenge of decision making on R&D projects
  2. Learn from the successes and failures of real-world R&D projects;
  3. Work in small, highly interactive interdisciplinary groups;
  4. Hear about first-hand experiences from industry experts.
This course receives a 9.5 from participants

This course receives a 9.5 from participants

Address

Kasteel Oud Poelgeest B.V., Poelgeesterweg, Oegstgeest, Netherlands
View on Google Maps

I know enough, let's

Start learning

Stay updated about this course