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Program Overview

Pharmaceutical and medical device manufacturers encounter constant threats and challenges. One serious threat is a breach of cybersecurity during the product life cycle and/or during postmarket management. Other challenges to industry include patient-focused drug development, labeling of biosimilars, and regulations for medical device software, among others. The FDA recently issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The FDA is also considering guidance on other key regulatory drug and device issues. Register now for this informative webinar to learn from two top FDA regulatory lawyers who will assist you in better understanding these critical issues.

Who Should Attend

  • Practicing attorneys who regularly represent pharmaceutical and medical device companies
  • In-house and outside counsel who want to broaden their knowledge of recent and proposed FDA Guidance
  • Attorneys who advise clients on FDA regulatory issues
  • Attorneys interested in cybersecurity

What You Will Learn

  • The application of FDA’s Guidance for Industry regarding Postmarket Management of Cybersecurity in Medical Devices
  • Regulatory issues facing drug and medical device companies in 2017
  • Possible additional areas of consideration for future FDA Guidance for Industry

Speakers

Peter F. McLaughlinPeter F. McLaughlin is a partner in Burns & Levinson’s Boston office. He advises U.S. and international clients on their handling of personal information, with particular emphasis on international data transfers and the privacy and security of health data. Currently, Peter advises clients across industry sectors with respect to rules governing employee, customer, and patient data; responding to regulators from the Federal Trade Commission, U.S. Department of Health and Human Services, and state attorneys general; and supporting post-enforcement compliance obligations.




Mauricio F. PaezMauricio F. Paez is a Partner in Jones Day’s New York City office. He advises Fortune 100 companies on legal issues concerning data privacy, cybersecurity, information management, and cyber governance matters. Mauricio assists clients in responding to cybersecurity breaches and government cyber investigations, identifying and managing global compliance and liability risks related to privacy and cybersecurity, and developing and implementing information management and governance best practices. He assists clients in developing and implementing worldwide policies and compliance procedures for safeguarding personal and company information, cross-border transfers of data, and vendor security oversight and management.


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