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This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time!
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Pharmacovigilance is required through the entire life cycle of a drug – starting from preclinical development stage, going through continues monitoring till regulatory approval as well as spanning post-market stidues. Discover with Meditrial all aspects of European Pharmacovigilance and Drug Safety that include collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies. Upon completing a course, you will take a final test to receive a digital certificate that can be printed.
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With the new Medical Device Regulation now in force as of 26 May 2021, Meditrial has organized this live event reserved for our customers and partners, to help you understand what changes impact you and manage the transition for ongoing and new clinical trials. Thus, this training will allow you a quick and rapid upgrade of your trials to the updated regulations according to MDR.
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This course describes key principles of general safety and performance requirements. In this video we will discuss in detail article 56 of IVDR and will give practical advices on how to plan and prepare for the IVDR. Finically, we will explain what is the performance evaluation and which periodic deliverables and when need to be updated accordingly.