Next Clinical Development online course starting date: October 31st, 2022
Question-based clinical development (QBCD) is a unique approach to designing a rational, efficient pathway for developing a new biomedical product. In this 5-week online course, you’ll learn the principles behind QBCD and how this approach can be applied to real-world R&D projects as described in our recent article (De Visser et al., Nature Biotechnology, Jan. 2020). In this course, you will also learn how to use our free Questions Optimizer Calculator tool.
Next Market Approval course starting date: November 7th, 2022
Obtaining market approval is an important step in the development of a new biomedical product. In this 5-week online course, you’ll learn how to identify the relevant regulatory guidelines that will steer you through the development process using our free Market Approval Navigator tool. This course uses real-world case studies such as the development of a gene therapy product and also a fictitious mRNA-based vaccine to familiarize you with common issues that can arise during product development, and you’ll learn how to assess an IMPD (Investigational Medicinal Product Dossier).
A limited number of scholarships are available for post-graduate biomedical professionals currently working at a university, university medical center, research center, or hospital in the Netherlands. These scholarships provide a 50% discount on the course fee. You can find more information and apply for a scholarship here.
Introducing the tool: the Clinical Trial Decision Tool
In collaboration with the Dutch CCMO (Central Committee on Research Involving Human Subjects), the Paul Janssen Futurelab developed the Clinical Trial Decision Tool. This free tool will help you determine whether your study involving a medicinal product is considered a clinical trial, a low-intervention trial, or falls outside the scope of the EU Clinical Trials Regulation CTR 536/2014, which is effective since January 31, 2022. You can access the Clinical Trial Decision Tool here.
Updated Committee Finder tool
The Paul Janssen Futurelab Committee Finder tool will help you find a suitable medical research ethics committee and (if applicable) other committees or organizations that will review your clinical trial application. This tool has now been updated to take into account the new EU Clinical Trials Regulation CTR 536/2014. You can access the Committee Finder tool here.