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Wednesday, June 29 • 10:30am - 11:45am
#317: Global Medical Device Development: Regulatory Concordance or Discordance?

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-558-L04-P; CME 1.25; IACET 1.25; RN 1.25

Developing medical devices for a global environment is difficult, with regulatory authorities working to regulatory convergence not harmonization. Participants will explore the latest developments from the International Medical Device Regulators Forum and Asian Harmonization Working Party to guide global device development decision-making.

Learning Objectives

Describe the growing regulatory landscape for medical devices; Discuss how to apply the advancements toward a converged regulatory environment for necessary global regulatory support to create more streamlined global development plans.


Mary Ann Smith, MS, RPh


Industry Perspective
Anthony D. Watson, MBA, MS

Health Canada Perspective
Nancy Shadeed


Mary Ann Smith

DRA Policy Head of Medical Device and Combination Products, Novartis Pharmaceuticals Corporation
Mary Ann Smith is Regulatory Policy Director, Digital Medicine & Devices, with Novartis since 2009 focused on software as a medical device, technology applications and enabled clinical trials, combination products and regulatory strategy. Ms. Smith has regulatory experience at Nektar... Read More →


Nancy Shadeed

Special Advisor, International Programs Division, Health Canada
avatar for Anthony Watson

Anthony Watson

Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in... Read More →

Wednesday June 29, 2016 10:30am - 11:45am EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session