SURVEY: Identifying the Barriers to Effective Clinical Quality Oversight — View Results!
Thursday January 25th, 2018
We surveyed 150 clinical quality, compliance, and operations professionals prior to an October 2017 event, inquiring about their top challenges, concerns, and obstacles relating to effective clinical quality oversight.
• Do you feel your company is ICH E6 R2 compliant?
• What are the biggest barriers, challenges or obstacles related to optimizing quality?
• Do you feel you are effectively documenting/demonstrating vendor oversight?
• Which vendors are the most difficult to oversee?
• What do you feel is your most effective tool/process to oversee clinical vendors?
Featured case study presentations include:
PFIZER CASE STUDY: RISK MANAGEMENT MODERNIZATION
Examining the Evolution of Risk Management Post-ICH E6 R2 and Outlining the Critical Changes That Have Occurred
Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER
ACADIA CASE STUDY: SHIFTING TO PROACTIVE RISK MANAGEMENT
Examining a Small Company’s Transition From Reactive Issue Resolution to ICH E6 R2 Compliant Proactive Risk Management and a Continual State of Inspection Readiness
Maryann Livolsi, MSN, RN, RQAP-GCP, Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALS
Stefan van den Akker, M.Sc., Director, R&D Quality and Risk Management, ACADIA PHARMACEUTICALS
TESARO CASE STUDY: STANDARDIZING GxP SOPs
Establishing a Foundation of Base Processes and Action Sequences That Are Consistent Across the Organization for Identification and Mitigation of Risk
Dan Greenwood, Senior Director, Quality Assurance, TESARO
ExL’s Proactive GCP Compliance attracts an audience of senior-level clinical quality, compliance and operations executives from pharmaceutical, biotechnology, and device companies. If this represents the audience to which you’d like to showcase your company’s services and products, then contact Justin Kreamer at 917-932-0429 or firstname.lastname@example.org, to learn more about the sponsorship and exhibition opportunities that are available.
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