Cybersecurity Regulations and Policy: FDA and Beyond

Cybersecurity has proven to be an increasingly important and high bar for regulatory professionals to meet for the regulatory submissions in many global markets. It is critical for regulatory professionals to understand how to interpret and prepare the necessary documentation to meet these expectations. This session will provide an overview of the standards, regulations, and guidance that are needed for a successful submission, including cybersecurity management plans, security risk management, threat modeling, secure design, vulnerability management, incident response, and vulnerability disclosure and related communication. The focus on this session will be on helping regulatory professionals both develop documents and guide their teams towards successfully meeting regulatory requirements.