A 60-minute cross-industry panel of experts will share their perspectives on conducting product risk assessments for biologics under a holistic, Quality-by-Design framework.

Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of how to apply these principles as described in the ICH guidelines. The discussion will be based on real-world experiences and best practices that produce more complete and comprehensive submissions.

Attendees will learn:
  • The do’s and don’ts of product risk assessments for biologics
  • Practical tips to meet the requirements of ICH Q8, Q9, and Q10
  • How digitization and vertically-integrated knowledge management can help to organize and facilitate risk assessments
Topics Covered
  • For product risk assessment, what is different for biologics?
  • What should a team do to prepare for a product risk assessment? What work needs to be completed first?
  • What are the major stumbling blocks to avoid when executing a product risk assessment for an advanced biologic?
  • Risk assessments are often considered a checkbox activity and not fully utilized to drive product and process understanding. Can you provide a real-world example of how taking an iterative approach to risk assessment drives better product quality?
  • Where does the product risk assessment fit in context to an entire QbD program?
  • Should you expect regulatory relief by using QbD-based product risk assessments?