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Cybersecurity Unauthorized

12.0
RAC Credits
Virtual Programs Virtual Programs
Tuesday, 08 March 2022 (9:00 AM) - Wednesday, 09 March 2022 (5:00 PM) Eastern Time (US & Canada)

Cybersecurity has proven to be a challenge not only with regard to ensuring the security of medical devices, but also preparing documents for regulatory submissions. Health authorities in many regions, including the US, Australia, Canada, and Japan, have released new cybersecurity guidance documents. In addition to premarket concerns, some of these guidance documents also include expectations for postmarket expectations. 

Medical device companies struggle to build security programs into quality systems that were likely not designed to address typical security issues such as hardening, vulnerability management, and global incident response. 

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 benefit from better understanding of how to translate regulatory expectations into concrete design and development activities. 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.

Registration Fees & Deadlines

17 January 2022 - 8 March 2022: Member $970.00 | Nonmember $1,150.00

Learning Objectives

After this program, participants will be able to:

  • Better understand international regulatory expectations for medical device cybersecurity
  • Learn 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
  • 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 benefit from better understanding of how to translate regulatory expectations into concrete design and development activities. 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

Time Topic Facilitator
March 8, 2022  
9:00-9:15am Instructions and Overview of Technology 
9:15 – 9:30amWelcome & Introductions
What Questions do You Want Addressed
Michelle Jump
9:30 -- 10:15amTOPIC 1: FDA UpdateSuzanne Schwartz
10:15 – 10:30 amBreak 
10:30- 11:00amTopic 2: Kevin Fu: New Role at FDAKevin Fu
11:00 – 12:30 pmTOPIC 3: Introduction to global regulatory expectationsMichelle Jump
12:30 – 1:15 pmLUNCH 
1:15 – 2:15pmTOPIC 4: Submission Strategies for CybersecurityMatt Hazelett
2:15 – 3:15pmTOPIC 5: Successful Pre-SubsMatt Hazelett
3:15 – 3:30pmBreak 
3:30 – 4:30 pmTOPIC 6: Breakout: plan your submission from a given countryMichelle Jump
4:30 – 5:00pmDay 1 Wrap-UpMichelle Jump


TimeTopicFacilitator
March 9, 2022  
9:00 – 9:15amRecap of Day 1Michelle Jump
9:15– 9:45amTOPIC 7: Security vs PrivacyMichelle Jump
9:45– 10:15amTOPIC 8: Cybersecurity Standards: not your typical approachMichelle Jump
10:15– 10:30amBREAK 
10:30 - 11:45pmTOPIC 9: Product Security Programs: The 7 PillarsMichelle Jump
11:45-12:30TOPIC 9 cont.: Product Security Programs: The 7 PillarsMichelle Jump
12:30 – 1:00pmLUNCH 
1:00– 1:45pmTOPIC 10: Fireside ChatSuzanne Schwartz and Michelle Jump
1:45 – 2:45pmTOPIC 9 cont: Product Security Programs: The 7 PillarsMichelle Jump
2:45 –3:45pmTopic 11: Breakout: Tabletop exercise: “You’ve been hacked! Now what!”Michelle Jump
3:45-4:00pmBREAK 
4:00-4:30pmTopic 12: Musical Chairs: Who’s typically responsible for different aspects of a security programMichelle Jump
4:30 – 5:00pmRoundtableAll

Instructor:

Michelle Jump

Michelle Jump is the vice president of security services 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
Cybersecurity Policy Analyst at FDA

Kevin Fu

Kevin Fu
Acting Director, Medical Device Cybersecurity at U.S. FDA Center for Devices and Radiological Health

Suzanne Schwartz, MD MBA
Director, Office of Strategic Partnerships & Technology Innovation, Center for Devices & Radiological Health, US FDA

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

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 raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

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