About the Conference

Many changes are coming that will affect risk and health hazard determination and the practical conduct of recalls and other field actions. Center and Field reorganization, new HHE procedures, UDI implementation, the rollout of tools for benefit assessment and the use of real world evidence and OUS data on device performance, Case for Quality and TPLC alignment, and more.

Join the sixth annual MedTech Intelligence Medical Device Recalls conference for presentations, panel discussions, and networking with senior FDA and industry experts to learn about recent and upcoming changes and their practical impact on how companies manage the decision-making and execution of recalls.

What you will learn:

  • New FDA initiatives affecting recalls
  • New HHE procedures
  • UDI implementation and OUS mandates
  • Practical approaches to benefit-risk calculation
  • Data sources for device performance assessment
  • The hospital perspective on recall communications
  • Special recall issues with diagnostics, radiology, and software
  • Product liability implications of recalls
  • Best practices for recall termination
  • The challenges of global recalls

Who should attend:

  • RA/QA
  • Compliance officers
  • Medical officers
  • Legal
  • Risk management
  • Postmarket surveillance

CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

SPEAKERS AND DETAILS

  • Greg Ayers, MD, PhD - Head Post Market Surveillance, Associate Chief Medical Officer, Monitoring & Analytics and Therapeutic Care, Philips Healthcare
  • Contress Braxton, PhD - Office of Compliance, CDRH
  • Adrienne Brott - VP, Quality Systems & Post Market Quality, Global Surgery, Johnson & Johnson
  • Kimberly Brown Smith, MD, PhD – Clinical Team Leader, Office of Compliance, CDRH
  • Seth Carmody - Cybersecurity Project Manager, CDRH
  • Doug Dumont – Staff Fellow, Office of Surveillance & Biometrics, CDRH
  • Sara Dyson - Assistant VP, Risk Management, Medmarc
  • Donna Engleman – Chief, Allegation of Regulatory Misconduct Branch, Office of Compliance, CDRH
  • Chris Harvey - Senior Recall Strategist, Stericycle ExpertSOLUTIONS
  • Beverly Lorell, MD - Senior Medical & Policy Advisor, King & Spalding
  • Bruce A. McIntosh, Pharm.D., National Manager, Product Recall Office, National Center for Patient Safety, Veterans Administration
  • Tom Morrisey, Quality Assurance Advanced Technology, Edward Lifesciences
  • Steve Niedelman - Lead Quality System & Quality Consultant, King & Spalding
  • Terrie Reed – Senior Advisor for UDI Adoption, CDRH
  • Adam Saltman, MD, PhD – Medical Officer, Office of Compliance, CDRH
  • Pat Shrader - Sr. Counsel, Hogan Lovells, Former VP, Global Regulatory Affairs, Medtronic
  • Kelly Stalford - Associate Manager, Post Market Regulatory Compliance, Stryker
  •  Bleta Vuniqi - Division of Manufacturing & Quality, Office of Compliance, CDRH
  • Nick Walker – Scientific Lead & Regulatory Reviewer, Diagnostic X-Ray Systems Branch, OIR/CDRH
  • Weiping Zhong - Global Director, QA/RA Risk Management, Clinical Evaluation, Cybersecurity Safety Risk, Statistics, GE Healthcare

  • When

  • Monday, May 14, 2018 - Tuesday, May 15, 2018
    8:30 AM - 4:00 PM

  • Where

  • Hogan Lovells
    555 13th Street NW
    Washington, DC 20004

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