Obtaining market approval is an important step in the development of a new biomedical product. In this course you’ll learn how to find and interpret the relevant regulatory guidelines that will steer you through the development process. Real-world case studies, including the development of a gene therapy product and a fictitious mRNA-based vaccine, are presented to familiarize you with issues that can arise during development, as well as how to assess an Investigational Medicinal Product Dossier (IMPD).
Amsterdam institute for Immunology and Infectious diseases
This fall, we are pleased to offer three online learning-by-doing courses, including our all-new Market Approval course. Our courses are for post-graduate biomedical professionals currently working in industry, academia, Knowledge Transfer Offices (KTOs), or regulatory authorities. In these courses, you will be guided by world-renowned experts, including real-time video conferences with teachers and other participants, providing a highly interactive experience.
In addition, our courses give you access to unique tools designed to help you draft a license agreement (the License Agreement Builder), find your way through the regulatory jungle (the Market Approval Navigator), and develop the most efficient clinical development program (the Questions Optimizing Calculator).
For each course, we have a limited number of scholarships available for participants currently working at a Dutch university, university medical center, research center, or hospital.
Start date: | |
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Location: | online |
Organisor |
Paul Janssen Futurelab Leiden |
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