3rd European Clinical Quality Oversight Forum  -

3rd European Clinical Quality Oversight Forum
25–26 February 2019
London, United Kingdom

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

Agenda – 3rd European Clinical Quality Oversight Forum

We are currently shaping the agenda through research with industry professionals to identify current trends, areas of interest and common challenges so we can be sure the topics selected for sessions reflect the industry’s needs and wants. If you’d like to be involved in this process and help shape the agenda and/or get involved as a speaker, panelist or roundtable moderator, please contact Kristen Hunter at 212-400-6241 or khunter@exlevents.com.

Topics we are considering for this year’s program include:

  • Interpreting and Aligning with ICH E6 R2
  • Evaluating the impact of ICH E6 R2 on Oversight
  • Understanding Quality Tolerance Limits and How to Develop Them
  • Reviewing your Trial Master File from the MHRA Perspective
  • Examining the impact of EU CTR
  • Achieving a Confident State of Inspection Readiness
  • Optimizing Data Integrity through Effective Oversight
  • Executing Effective Risk-Based Monitoring
  • Identifying Strategic Clinical Vendors
  • Measuring the Clinical Quality of your Partners
  • Managing Quality between Sponsors and CROs
  • Initiating a Quality by Design Approach
  • Prioritizing Data Quality to Proactively Identify Possible Noncompliance
  • Overcoming Global Compliance Challenges
  • Developing a Risk-Based Vendor and Site Audit Strategy
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