9th Clinical Quality Oversight Forum – 9th Clinical Quality Oversight Forum

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.

Event Features

REGULATORY UPDATE: FDA INSPECTIONS

Understanding Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Compliance and Enforcement
Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research (CDER), FDA

SENIOR LEADERS PANEL: PRIORITIZING QUALITY

Driving Quality From the Top-Down to Build a Successful Quality Culture
MODERATOR
Greg Dombal,
Chief Operating Officer,
HALLORAN CONSULTING GROUP
PANELISTS
Grace Crawford,
VP Clinical Quality and Compliance,
MEDIMMUNE
Paul Houri,
Vice President, Head of BioResearch Quality Assurance,
JOHNSON & JOHNSON
Melissa Mudrick,
Vice President and Global Head, R&D Quality and Compliance,
BIOGEN

INDUSTRY SURVEY RESULTS: CRO OVERSIGHT EFFECTIVENESS AND IMPACT

Benchmarking and Understanding the Industry’s CRO Oversight Practices, Their Impact, and Effectiveness With New Industry Research Results
Michael Wilkinson,
Senior Research Analyst,
TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
Beth Harper,
President,
CLINICAL PERFORMANCE PARTNERS, INC.

REAL CASE STUDIES OF AVOIDABLE FAILURES

Examining Fundamental Failures by Top CROs Identified Through Audits, and How Effective Oversight Would Have Prevented Them
Sharon Reinhard, M.S.,
Clinical Compliance Solutions, Consultant on Assignment,
MERCK

Who Should Attend

This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • 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/Auditor
  • 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