All your learning in one place

In this very short course, you will get started with an overview of medicines research and development.

The courses of this module will explain non-clinical studies in detail, the concepts of pharmacogenetics/genomics and more.

This module contains courses on clinical development and trials, including statistics, ethics, the role of participants in trials and more.

Important note: term ‘regulations’ can be used in
different contexts while an EU regulation is a legal act of the
European Union that becomes immediately enforceable as law in all member states
simultaneously. EU regulations can be distinguished from EU directives which,
at least in principle, need to be transposed into national law.

The courses in this module will give you an overview on the Medical Devices and their regulatory framework. You will learn about the history of the Medical Devices, different classifications, the role of Notified Bodies and Conformity Assessment, CE marking and re-certification. You will also acquire knowledge about the Medical Devices development and the lifecycle management under the MDR and IVDR and new technologies in the context of Medical Devices and in vitro diagnostics (IVDs). You will learn about the general principles for market access and market access for Medical Devices and the different aspects of Value-based innovation. These courses also provide key definitions about Health Technology Assessment (HTA) in Medical Devices and HTA principles in Medical Devices and in vitro diagnostics (IVDs).