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.