Asia-Pacific – Taking Device Clinical Development to the US & Europe

Presented by

Nach Dave, RPh. MSc, Vice President, Development Strategy and Marlis Sarkany, MD Senior Medical Director

About this talk

Medical devices play an increasingly critical role in the health and quality of life for 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 the device trials are designed and executed. In this webinar, the presenters draw on their extensive experience in both medical device and clinical product development to share what manufacturers need to know. The pair will 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. 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 in the USA. By understanding this evolving regulatory landscape, device manufacturers across the globe can better position their products to adapt to these changes in support of their device development programs. What You Will Learn • An Overview of the EU MDR/IVDR Regulations for Device Development • Ways to accelerate and optimize device development by partnering with the US FDA • Factors for clinical development success of combination products in therapeutic and aesthetic dermatology, including a selection of relevant evaluation scales, training of investigators, and quality of study monitoring

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