30 November 2017 | Pope Woodhead, UK

Structured benefit-risk assessment became a high priority with adoption of ICH M4E(R2), which provided a new format for benefit-risk conclusions within regulatory submissions. The guideline has been widely implemented this year, including by EMA in January and FDA in July.

This webinar led by Dr Steve Mayall, a Principal Consultant and expert in the benefit-risk area, provided an update on key aspects of benefit-risk assessment in today’s environment, highlighting practical experiences and challenges.

The webinar covered:

  • Current status of the benefit-risk assessment field
  • The product perspective – using appropriate frameworks, methodologies and visualisations
  • The organisational perspective – building robust life-cycle benefit-risk assessment across a portfolio of products

Speaker: Steve Mayall at Pope Woodhead