JLABS is hosting a session on regulatory and compliance requirements for medical devices in Canada. What can you do to stay ahead of the curve when it comes to FDA and Health Canada submissions?
This session will cover FDA and Health Canada regulatory requirements, specifically FDA processes clearances, Premarket Approval (PMA), and Combination Products) and Health Canada’s medical device licensing requirements. This session will help you pinpoint the information you need to develop a regulatory strategy, and then hit the ground running. Learn the next steps you need to take to bring your device to market.
Join the expert speakers and learn the next steps you need to take to bring your device to market.
Young Kim | Director of Regulatory Affairs, Johnson & Johnson Medical Companies
Young Kim is the Director of Regulatory Affairs at Johnson & Johnson Medical Companies in Markham, Ontario. Johnson & Johnson Medical Companies operates as an umbrella organization that markets and distributes products from a number of different medical device companies. She also works to shape the Canadian regulatory environment as a member of the Regulatory Affairs Steering Committee of MEDEC, Canada’s Medical Device industry association and is a co-chair of the MEDEC Pre-submission team focusing on regulatory issues related to pre-market authorizations of medical devices in Canada. Young also is a member of the Regulatory Affairs Professionals Society (RAPS) exam committee focusing on the Canadian Regulatory Professional Certification Exam.
Sharon Starowicz | Director, Regulatory Policy Innovation, Global Orthopaedics, Johnson & Johnson
Sharon Starowicz is the Director of Regulatory Policy Innovation, Global Orthopaedics, for Johnson & Johnson, where she is responsible for providing strategic regulatory guidance and expertise and, with a focus on the external environment, shaping the evolving regulatory policies that impact our industry. Sharon 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 the US Food and Drug Administration as a Biomedical Engineer/ Scientific Reviewer, where she reviewed engineering and clinical data submitted in support of orthopedic device approvals (510(k)s, IDEs and PMAs). She has worked for Johnson and Johnson for 19 years in 3 operating companies, having previously been a member of the Indigo Medical, Inc. management board with responsibilities for regulatory affairs, clinical affairs and quality systems, and having regulatory affairs and regulatory compliance responsibilities for DePuy Orthopaedics, Inc. prior to joining DePuy Spine, Inc. in 2004.
Date:November 10, 2016
Location: 3600 Steeles Avenue East, Room D109, IBM Canada Offices, Markham, Ontario