ICH E6 GCP Interactive Workshop – How to Build A Sponsor Risk Management Program
Presented by FDAnews and Technical Resources International Inc.
For clinical trials, it’s a new ball game. The ICH E6 (R2) guidelines now require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors.
Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. Have you established your program yet? Is your maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:
Date: Tuesday, February 19, 2019
Session Title: Vendor Performance Metrics and KPIs
Participation: Moderator – Linda B. Sullivan, Executive Director, Metrics Champion Consortium
Date: Wednesday, February 20, 2019
Track: Mastering an Outsourcing Strategy
Panel Discussion: Ensuring Harmony between All Stakeholders – Sponsor, CRO, and Site – When Site Sourcing
Topics to be discussed: Working with stakeholders on setting appropriate site budgets, site contracting, site identification, selection of sites, and site oversight/ management
Moderator: Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.
Panelists: Jennifer Trevor, Ph.D., Sr. Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma