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ExL’s 4th European Clinical Quality Risk Management Forum

The European Clinical Quality Risk Management Forum in London on 24–25 February 2020, provides a forum for senior-level clinical quality, compliance and operations executives from leading pharma, biotech and medical device companies, to candidly discuss strategies for ensuring trial integrity through proactive clinical risk management.  Learn from this experienced group and take-away proven, results-driven, risk-based strategies for optimizing your company’s clinical quality to achieve a continual state of inspection readiness.

15% Discount Code: 798720AVOCA

Please join us for the following session:

Day One – Monday, 24 February – 14:00

DEFINE THE FRAMEWORK AND CRITICAL ELEMENTS OF AN EFFECTIVE OVERSIGHT PLAN: ICH E6 (R2) REQUIREMENTS FOR VENDOR OVERSIGHT

Sponsor Responsibilities for Quality Management (Section 5.0 of ICH E6 (R2)) requires that Sponsors oversee trial-related duties and functions, including those that are subcontracted by CROs (5.2.2).The use of best practices for pro-active quality management and quality oversight of outsourced clinical projects is essential for both Sponsors and CROs to achieve the right balance between meeting timelines, ensuring cost containment, driving compliance, and achieving the highest level of quality.

Key Takeaways:

  1. The components that comprise a comprehensive framework for effective Quality Oversight of your CRO partner.
  2. How to implement quality oversight.
  3. The critical elements for a successful CRO-Vendor oversight plan including what to measure so risk is reduced, and outcomes are improved.

Presented by: Brigid Flanagan, Senior Consultant, The Avoca Group

Brigid Flanagan is a research professional with 20+ years in clinical operations. In her role as Senior Consultant for The Avoca Group, Brigid provides input on operational plans, vendor qualification, and oversight for pharmaceutical clients conducting trials in the US and EU. She is passionate about research and the benefits it offers to participants. Brigid has been an active member of ACRP since 1998 and most recently was Vice Chair of their Professional Ethics Committee. She has an undergraduate degree in Sociology, trained as an RN in the UK, and completed a Masters in Bioethics at Union Graduate College/Mount Sinai School of Medicine in New York, NY.

 

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Attend a webinar on January 29: Do You Have an Effective Oversight Plan of Your CRO-Vendor? How Are You Measuring It? ICH E6 R2 Requirements for Vendor Oversight