Medical Device Regulation: Finding Your Path to Success

Successfully navigating the medical device regulatory landscape requires a well-defined and understood approach and knowledge of best practices specific to the device field. While device and drug development follow the same basic steps, there are key differences in regulations, approval pathways, and clinical investigations required for medical devices in the United States and European Union.

There are also clear definitions in the clinical investigations needed to support marketing approval, in part due to the durable nature of devices, which may be implanted in a patient’s body for extended periods. Understanding where the evolution of devices and drugs diverge is critical to ensuring proper planning along the development continuum, from discovery to post-market surveillance.

This webinar will explore the development process, the changing regulatory environment, and the device approval pathways to help sponsors optimize the likelihood of regulatory and commercial success. The speakers will discuss these topics:

• Key distinctions between devices and drugs
• The regulatory landscape in the U.S. and EU
• The device development process
  • Looking at key stages: discovery through post-market surveillance
• Classification of medical devices
  • Important definitions
  •  Defining risks and classification differences between the U.S. and EU
• Applying ISO
  • Pre-risk analysis questionnaire
• Quality by design
• Approval pathways

Speakers

Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research

Joanne Emmett has been part of the clinical research industry for 20+ years with a keen focus on operational design and delivery. Ms. Emmett started her career in academia within transplant research and proceeded on to cardiovascular research involving valve and imaging trials. Once joining the CRO business space in 1995, she was engaged as a CRA, LCRA and Project Manager working on trials in CNS, Oncology, Respiratory, Cardiovascular Device and several diagnostic programs. Ms. Emmett took her front-line delivery experience to the next level and moved into oversight and department leadership specializing in Clinical and Project Management Delivery, spending time at PRA and joining Premier Research in early 2011.

Since then, Ms. Emmett, has been responsible for the operational delivery structures and planning for both clinical and project management. She has focused on the key needs and standards within therapeutic and medical device and ensuring core process designations for staffing and oversight, including the unique regulatory and scientific avenues required for medical device.

Ms. Emmett has been engaged over her career with ACRP, chairing the Poster Committee in 2006 and moving onto Chair the Annual ACRP meeting in 2007. She also spent time with development and implementation of the Post Graduate Clinical Research Program at Humber College in Toronto. Ms. Emmett has her PMP designation, Management and Business Administration Certificate from the American Management and Business Administration Institute, CCRA from ACRP, Post Graduate Clinical Research Certification and BSc from the University of Western Ontario in London, Canada.

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Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research

As Premier Research’s lead regulatory official, Lisa Pitt provides strategic guidance and oversees the company’s regulatory affairs service offerings. Dr. Pitt has more than two decades of experience in the pharmaceutical and contract research industries and extensive expertise in small-molecule and biologic pharmaceutical product development, from early phase through registration and post-marketing.

She oversaw regulatory activity for global product development teams at MedImmune as Director of Regulatory Affairs and served as Director and Principal Regulatory Affairs Consultant at PAREXEL. She also held regulatory positions at Novartis Pharmaceuticals, and immediately prior to joining Premier Research, was a senior regulatory project manager at the U.S. Food and Drug Administration, responsible for drugs and biologic products intended for the treatment of inherited metabolism disorders.

Dr. Pitt holds a doctorate in pharmacy from the University of Maryland School of Pharmacy, a Master of Science and Jurisprudence from Seton Hall Law School, and a bachelor’s degree in biological sciences from the University of Delaware.

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