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ExL’s 9th Clinical Quality Oversight Forum

October 10-12, 2018  |  Sonesta Hotel Philadelphia  |  Philadelphia, PA

ExL’s 9th Clinical Quality Oversight Forum focuses on ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors and sites. This forum acts as the annual gathering for clinical quality, operations, management and audit professionals to engage and candidly share their experiences, struggles, obstacles, and achievements when working with varying clinical partners including CROs and investigator sites. Learn from this experienced group and take away proven, results-driven, risk-based strategies for optimizing your company’s clinical vendor and site oversight approach.

 

Join Steve Whittaker for the following sessions:

 

Main Conference Day Two  |  Friday, October 12

Morning Tracks:  TRACK A – 11:15AM – 12:00PM

The Impact of (R2) on Sites

Evaluating the Impact of ICH E6 (R2) on Sites and How Sponsors Can Proactively Manage This Change to Optimize Quality

  • Examining the elements of ICH E6 (R2) that directly impact sites
  • Recognizing that risk-based monitoring shifts QC from the responsibility of the Sponsor/CRO to that of the site
    • Exploring the impact of this shift and how to ensure sites understand their changing role
  • Ensuring data quality and integrity at the site-level

 

Day Two Afternoon – 1:45PM – 2:45PM

Panel Discussion: Inspection of Oversight Activities

Discussing How Oversight Activities and Processes Were Evaluated During Inspections

  • Sharing panelists’ experiences with inspections related to oversight activities
  • Understanding what kind of documentation was used to show oversight and how it was received
  • Discussing expectations related to escalation plans and CAPAs
  • Resulting procedural changes to oversight as a result of an inspection
  • Recommendations for being inspection-ready when it comes to demonstrating effective oversight

 

Steven B. Whittaker
Senior Consultant, The Avoca Group

Steve Whittaker is Senior Consultant with The Avoca Group. He is also a lead consultant for the pharmaceutical, biotech, and CRO industries where he provides expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution plans. His experience in drug development leadership roles, combined with his established professional network across these industries, provides unique and valuable insights for organizational leaders.
In 2009, Steve retired from Eli Lilly and Company, where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform. Steve also led the Global Clinical Research Sourcing Office and Lilly’s Project Management Center of Excellence.

 

To schedule a meeting with an Avoca representative at this event, contact us.