Cybersecurity Unauthorized (April 2023)

12.0
RAC Credits
In-PersonIn-Person
Thursday, 20 April 2023 (9:00 AM) - Friday, 21 April 2023 (4:00 PM) Eastern Time (US & Canada)
5635 Fishers Ln
Rockville, Maryland, USA, 20852-1796

Securing medical devices and documents for regulatory submissions from cyberattacks is challenging. Many medical device companies struggle to retrofit their security programs to address hardening, vulnerability management, and global- incident response.

Health authorities spanning the US, Australia, Canada, and Japan, have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes expectations for post-market expectations.

This interactive, in-person workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity.

Technical staff will get a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of gaining green lights from regulators while also teaching them how to establish trust with customers concerned about risk related to medical devices on their networks.


REGISTRATION FEES & DEADLINES

January 18, 2023 – March 20, 2023: $1135 Member | $1340 Nonmember

March 21, 2023 – April 20, 2023: $1340 Member | $1570 Nonmember


After this program, participants will:

  • Thoroughly understand international regulatory expectations for medical-device cybersecurity
  • Know the main components of a product security program aligned with global expectations
  • Understand how to use pre-submissions to reduce the likelihood of cybersecurity-related deficiencies
  • Be able to build more successful regulatory submissions

  • Who Should Attend?

    This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations. Technical staff will gain a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of successful submissions and help establish trust with customers who have concerns about risks related to medical devices on their networks.

    Agenda

    • The challenge of security: What makes this issue unique?
    • Introduction to global regulatory expectations 
      • US, Canada, EU, Australia, China, Japan, France, Germany, IMDRF, etc. 
      • Breakout: plan your submission from a given country 
    • Security vs privacy: understanding the relationship and uniqueness 
      • Pre-submission strategies for successful cyber submission 
      • Submission strategies: What to include and what to leave out
      • Lessons learned: What regulators would like you to know about your submission
    • Cybersecurity standards: not your typical approach 
    • Product security programs: the 7 pillars 
      • Governance 
      • Design and testing 
      • Risk management 
      • Labeling and communication 
      • Vulnerability management 
      • Incident response 
      • Breakout: tabletop exercise: “You’ve been hacked! Now what?” 
      • Supply chain 
      • Musical chairs: Who’s typically responsible for different aspects of a security program?  

      Instructors:

      Michelle Jump

      Michelle Jump

      Michelle Jump, is the Vice President of Security Services, Medical Device Cybersecurity at MedSec, where she is responsible for providing strategic leadership, training and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management.

      Matthew Hazelett

      Matthew Hazelett - INVITED

      Matthew Hazelett is a Cybersecurity Policy Analyst, Food and Drug Administration Center for Devices and Radiological Health Office of Product Evaluation and Quality Clinical and Scientific Policy Staff at the FDA.

      Hazelett started at the FDA as a biomedical engineer within the Implantable Electrophysiology Devices Branch at the Center for Devices and Radiological Health (CDRH). His review areas include pacemakers, defibrillators, leads, and supporting devices, such as programmers and home monitors. Since starting at FDA, Hazelett developed a review focus in cybersecurity, participates in cybersecurity guidance development, and supports cybersecurity vulnerability assessments and reviews across CDRH. He became the cybersecurity policy analyst in FDA’s Office of Product Evaluation and Quality a year ago, focusing on cybersecurity policy development and implementation. Hazelett also has worked for a medical device research and development company as a test engineer and test manager overseeing device verification and validation testing.

      Linda Ricci

      Linda Ricci - INVITED

      Linda Ricci is the Director, Division of All Hazard Response, Science and Strategic Partnerships at the FDA. Ricci began her career developing AI solutions in the defense industry before moving to the medical-device field as a software engineer. She helped to develop several diagnostic cardiology devices and has participated in all phases of product life cycle development. Ricci moved to the FDA in 2005, and has held several roles including scientific reviewer and branch chief within the Division of Cardiovascular Devices and Associate Director for Digital Health within the Office of Device Evaluation. Ricci is the Director for the Division of All Hazard Response, Science and Strategic Partnerships. This position involved leading teams focused on medical-device cybersecurity, standards and conformity assessment, women’s health, pediatric and special populations, patient science and engagement, partnerships and regulatory science, and emergency response including COVID-related device shortages. She has degrees in electrical engineering, medical engineering, and public health.

      Registration fee includes:

      • Breakfast and lunch each day
      • Continuous beverage break service
      • Complimentary WiFi
      • Complimentary parking

      Location

      RAPS Headquarters

      5635 Fishers Ln
      Terrace Level
      Rockville, MD 20852


      Parking

      Parking at RAPS HQ is free with a validated ticket. Please make sure to bring your parking ticket to registration for validation. Overnight parking is not allowed.


      Hotels

      Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr
      1750 Rockville Pike
      Rockville, Maryland, 20852-1699, USA
      Telephone: (301) 468-1100
      Hotel Website
      Distance to RAPS HQ: .8 miles
      Directions to RAPS HQ


      EVEN Hotel Rockville
      1775 Rockville Pike
      Rockville, MD 20852
      Telephone: (301) 881-3836
      Hotel Website
      Distance to RAPS HQ: .7 miles
      Directions to RAPS HQ


      Be Well Policy

      RAPS has initiated a Be Well policy, with consent required during the registration process. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while onsite at RAPS HQ, you will reconsider your participation at the event.

      To ensure your personal safety and comfort during this event, RAPS is committed to robust and transparent communications during the event. We encourage all participants to monitor RAPS social media channels and download the conference app to their mobile devices to receive up-to-the-minute updates.

      Cancellations and Refunds

      All cancellation requests must be submitted in writing to support@raps.orgCancellation requests received by Friday, 17 March 2023 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 17 March 2023 will be non-refundable, except in cases of documented medical emergencies.   RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.

      Photography Policy

      By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution.

      Substitutions

      Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

      Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.

      Questions

      Contact the RAPS Support Center:

      Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.  

       

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