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, 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. 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. Register for the webinar today for an in-depth look at the changes being proposed and the requirements that will need to be met by device manufacturers willing to do business in Europe and beyond.
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
Nach Dave, RPh. MSc
Vice President, Development Strategy
Nach Davé provides strategic and commercial input for Premier Research’s business activities. He brings more than 20 years of experience in the pharmaceutical and contract research industries to the position. He previously served as the Vice President of Regulatory at Premier and has been in leadership positions at both CROs and sponsor companies.
In his current role, Mr. Davé brings innovative solutions and grow Premier’s footprint in the areas of medical device development, real-world evidence, and government relations. He is keen to explore how innovative technology like AI, ML, and other developments can best support the growth of Premier’s business.
Mr. Davé holds a master’s degree in drug regulatory affairs from Long Island University and a bachelor’s degree in pharmacy from the University of Sciences-Philadelphia. He is a registered pharmacist.
Marlis Sarkany, MD
Senior Medical Director
Marlis Sarkany has over 30 years of experience in phase 1 to phase 4 global clinical development in dermato-oncology, aesthetic dermatology, acne, rosacea, onychomycosis, and orphan skin diseases and over 6 years of experience in the global clinical development of medical devices, including photodynamic therapy and hyaluronic acid fillers.