Successfully Integrating Cybersecurity Risk Management into International Regulatory Submissions

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Successfully Integrating Cybersecurity Risk Management into International Regulatory Submissions

This is an On-demand recording from February 2019.

This webcast is device focused and is only intended to be applicable to the medical device sector.

Global regulatory submissions are becoming increasingly more stringent related to cybersecurity requirements.  One consistent expectation is that manufacturers provide evidence of effective cybersecurity risk management.  Being able to interpret what countries are expecting and how they leverage cybersecurity risk management is becoming critical for successful submissions.  It is also imperative to understand that safety risk management alone is insufficient for cybersecurity risk management.  This webinar will focus on three aspects:

  • How cybersecurity risk management impacts international regulatory submissions
  • What international regulatory submissions are looking for from cybersecurity risk management
  • Cybersecurity Risk Management 101 – What is the difference between safety risk management and cybersecurity risk management and what should your cybersecurity risk management include


Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 


Learning Objectives

Upon the webcast's conclusion, you will be able to: 

  • Understand the basic elements of cybersecurity risk management
  • Understand how cybersecurity risk management plays a role in submissions across the globe
  • Understand the difference between cybersecurity risk management and safety risk management


Who should attend?

  • Product Security Professionals
  • Risk Management Professionals
  • Regulatory Affairs Professionals within Medical Device Industry




Nicholas Werner, senior scientific advisor, regulatory affairs, Network Partners

Michelle Jump, vice president of cyber program initiatives, Nova Leah
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