Breakfast Roundtable: Eliminating the Headache of Global Safety Reporting to Investigators and Ethics Committees – Janssen & Celgene’s Journey

Join WCG and our Roundtable panelists for a discussion on Tuesday, April 30th, as we explore how biopharma companies are moving to centralize safety reporting distribution responsibilities, automate manual processes, eliminate paper reporting, and implement rules-based country alerting algorithms using a “Golden Standard” set of 110 local country regulations – all in an effort to streamline distribution and eradicate wasteful reporting to sites and ethics committees. Click here to register.

Our speakers will lead the discussion on:

  • How the industry is moving away from manual, multi-party distribution, to a centralized model where one group distributes safety reports directly to all global investigators and ethics committees
  • How manual processes in distribution can be automated, eliminating hours of work for each SUSAR or other safety document to be distributed
  • What can be done to limit – and even eliminate altogether – paper reporting
  • How a “Golden Standard” set of local country reporting rules allows pharmaceutical companies to distribute with precision, while maintaining compliance in accordance with local requirements
  • How to use a proven cost-savings/cost-avoidance business case for this transformation


Kate Lowther
Safety Business Unit Lead, Janssen

Nicole Monsees
Director, Clinical Systems Operations, Celgene

Steven Beales
Sr. Vice President & Market Owner Safety Reporting, WCG Clinical Services

Kendra Hayden
Business Transformation Program Lead, Safety Reporting, WCG Clinical Services