European Clinical Quality Oversight Forum -

European Clinical Quality Oversight Forum
February 7 - 8, 2017
London, United Kingdom

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

European Clinical Quality Oversight Forum – European Clinical Quality Oversight Forum

Following seven years of success and growth in the US and in response to continued requests, ExL is bringing our Clinical Quality Oversight Forum across the pond to London in February of 2017. The CQOF focuses on ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors and sites. This forum has the reputation for being 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.

Conference Chair

david-fryrear-photo1 David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE

Featured Sessions

balall-naeem REGULATORY PERSPECTIVE: CLINICAL SAFETY MANAGEMENT
Understanding the Correct Use and Application of the Reference Safety Information (RSI) in Clinical Trials
Balall Naeem, GCP Inspector, MHRA
rowe PFIZER CASE STUDY: A PROCESS FOR UNDERSTANDING ADHERENCE GAPS TO THE ICH E6 GCP AND ADDENDUM
Breaking Down the ICH E6 GCP Addendum into Each of the Requirements, and Developing and Mapping Metrics and Process Controls to Ensure Full Compliance
Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER
joy-e ASTRAZENECA CASE STUDY: DOCUMENTING VENDOR OVERSIGHT
Achieving Compliant Documentation of Proper Ongoing Engagement and Evaluation of Clinical Vendors
Joy Eldridge, Ph.D., Director, Quality and Risk Management, Early Clinical Development, ASTRAZENECA
tipsuda EISAI CASE STUDY: MHRA INSPECTION AND TMF FINDINGS
Examining a Case Study of an MHRA Inspection and the Resulting TMF Process Changes
Tipsuda Kongtong, MPH, Manager, Clinical Quality Assurance, EISAI INC.
susan TRANSCELERATE’S CLINICAL QMS INITIATIVE – ISSUE MANAGEMENT
Examining a Framework for Effectively Managing the Challenges in Clinical Development Issue Management
Susan Callery D’Amico, Vice President, R&D Quality Assurance, ABBVIE

Testimonials

testimonials

Who Should Attend

This conference is specifically designed for pharma, biotech and medical device professionals responsible for:

  • Quality Management/Clinical Quality Management
    • Clinical Quality Assurance/QA/CQA
    • Clinical Quality Control/QC/CQC
  • Clinical Operations/Management/Research/Development
  • Compliance/Clinical Compliance/Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Outsourcing/Vendor Management/Third-Party Management
  • Good Clinical Practice/GCP
  • Auditing
  • Clinical Risk/Risk Assessment
  • Regulatory Affairs
  • Medical Affairs

The event is also of interest to:

  • Investigative Sites
  • Academic Research Organizations
  • Central, Imaging and ECG Labs
  • IVRS Companies
  • EDC Companies
  • Other Clinical Service Providers
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