Upcoming Events

ICH E6 GCP Interactive Workshop – How to Build A Sponsor Risk Management Program

Presented by FDAnews and Technical Resources International Inc.
Tuesday-Wednesday December 11-12, 2018 • Raleigh, NC

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:

  • What the new guidelines require
  • How to establish your program step-by-step
  • Critical elements of starting your program: A walk-through
  • How to conduct risk assessment at both system and clinical-trial levels
  • Evaluating the risks: Your options
  • Risk mitigation and reporting strategies
  • Common pitfalls and how to sidestep them
  • And much more!

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SCOPE 2019

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
Carlos Orantes, CEO, Accel Research Sites
Linda Sullivan, CO-Founder & Executive Director, Metrics Champion Consortium

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