Sponsored Webcast: Successfully Integrating Cybersecurity Risk Management into International Regulatory Submissions

RAC Credits
Wednesday, 27 February 2019 (12:00 PM) - Wednesday, 27 February 2019 (1:00 PM) (Eastern Time (US & Canada))

27 February 2019

12:00 – 1:00pm EST

* 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 webcast 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

Registration Information 
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year. 

Need Assistance? Contact the RAPS Solutions Center at +1 301 770 2920, ext. 200.