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OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities

When: Thursday, June 13 | 11:15 am - 12:15 pm 
Where: Room 49 - Product Lifecycle Management Track
Level: All
Participant Type: Research & Development, Product Development, Regulatory/Clinical Affairs, Quality Control

 

Description

The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session of three, 15-minute presentations is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.

Attendee Takeaways

  • Learn the history of OSMA, its current strategic initiatives and the ways that OSMA engages with regulators
  • Receive an update on global regulatory changes impacting orthopedics, including challenges and opportunities in key regions
  • Understand future regulatory trends and opportunities, like NEST and global harmonization of regulatory and quality processes

Moderator

Elizabeth Wray is Director of Regulatory Affairs for Zimmer Biomet and has served in regulatory affairs roles in orthopedics for more than 12 years. Prior to joining Biomet in 2006, Ms. Wray was an analytical scientist at Pfizer. She received her B.S. in Biochemistry from Indiana University.

Speakers

Sharon Starowicz is the Director of Regulatory Policy Innovation, Global Orthopaedics for Johnson & Johnson, where she provides strategic regulatory guidance and expertise and, with a focus on the external environment, shapes the evolving regulatory policies that impact our industry. Ms. Starowicz has over 30 years of regulatory affairs experience, specializing in Class I, II and III orthopedic and spinal devices. She began her regulatory career at FDA as a Biomedical Engineer/Scientific Reviewer, where she reviewed engineering and clinical data submitted in support of orthopedic device approvals. She has worked for Johnson & Johnson for over 20 years. Ms. Starowicz is a Past President of OSMA and serves as its Industry Representative on FDA’s Orthopaedic and Rehabilitation Devices Advisory Panel. Ms. Starowicz holds a BS in Engineering Science and Mechanics and an MS in Engineering Mechanics from Virginia Polytechnic Institute and State University (Virginia Tech).

Ryan Belaney is Senior Director of Regulatory Affairs at Active Implants. Mr. Belaney served in Regulatory, Quality, R&D and Corporate Development roles for more than 15 years, including Director of Applied Research at RTI Surgical, Senior Director Regulatory Affairs and Quality Assurance at AgNovos Healthcare, Manager of Corporate Development and Senior Product Development Engineer at Wright Medical. He holds a Bachelor’s in Biology from the University of Mount Union and a Master’s in Biomedical Engineering from The University of Toledo.

Natalie Heck is Associate Director, Corporate Regulatory Affairs at Zimmer Biomet. Ms. Heck has more than 30 years of experience in the orthopedic industry. She has held various positions in regulatory affairs and quality engineering, including product lifecycle management from design to obsolescence. Her current position with Zimmer Biomet is in Corporate Regulatory Affairs, covering policies, procedures, intelligence and training. Key roles include participation on OSMA, AdvaMed and global industry working groups; initiating corporate communications on regulatory policies and regulatory intelligence; creation and administration of regulatory procedures and intranet page. Ms. Heck has been an OSMA member since 2011 and currently serves as a board member.