Australia Webinar: EU MDR and FDA: Key Points for Consideration - ERP Spain.com - España y América Latina

Medical devices play an increasingly critical role in the health and quality of life of millions of people worldwide. While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way device trials are designed and executed. Premier Research’s Nach Davé, Vice President, Development Strategy, and Marlis Sarkany, Senior Medical Director, draw on their extensive experience in both medical device and clinical product development to share what manufacturers need to know. They explore the latest US and European medical device regulatory pathways, agency expectations, and other critical best practices. To reflect the substantial technological and scientific advances made by the medical device sector and to respond to the need for regulations that would significantly tighten the controls around medical devices, the European Commission published the EU Medical Devices Regulation (MDR) on May 5, 2017 – which is fully applicable as of May 2020. These new regulations seek to set the standard for medical device regulation globally and impact the entire product development cycle, from concept to clinical trial conduct and post-marketing surveillance. Manufacturers will need to conduct more rigorous clinical investigations than ever on both safety and effectiveness to support their claims both in Europe and the US. By understanding this evolving regulatory landscape, device manufacturers across the globe can better position their product to adapt to these changes in support of their device development programs. This webinar takes an in-depth look at the changes being proposed and requirements that will need to be met by device manufacturers willing to do business in Europe, the US, and beyond. Presenters: Nach Davé, RPh, MSc, Vice President, Development Strategy Marlis Sarkany, MD, Senior Medical Director