10th Clinical Quality Oversight Forum – 10th Clinical Quality Oversight Forum
ExL’s 10th 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.
REGULATORY UPDATE: FDA INSPECTIONS
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Evaluate Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Inspections of Clinical Investigators and Sponsors Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA |
RISK-BASED OVERSIGHT
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Prioritize Oversight Activities With a Risk-Based Approach Resulting in a Continual Inspection-Ready State Michael Torok, Ph.D., Clinical Quality Assurance Head, ASTELLAS |
KEY FINDINGS FROM THE TUFTS CSDD-AVOCA VENDOR QUALIFICATION BENCHMARKING STUDY
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Quantify Vendor Qualification Practices and Experiences and Identify Improvement Opportunities
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![]() Kenneth A. Getz, MBA, Director of Sponsored Programs, Associate Professor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT |
![]() Dennis Salotti, Chief Operating Officer, THE AVOCA GROUP |
WORKSHOP: QUALITY TOLERANCE LIMITS
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Demonstrate the Steps for Defining and Implementing Appropriate Quality Tolerance Limits (QTLs) Through Case Study Examples and Hands-On Learning
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![]() Jonathan Rowe, Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER INC. |
![]() Stacy St. John, Director, Clinical Development Quality, GCP Quality Management Lead, PFIZER INC. |
REGULATORY UPDATE: FDA INSPECTIONS
|
![]() |
Evaluate Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Inspections of Clinical Investigators and Sponsors Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA |
RISK-BASED OVERSIGHT
|
![]() |
Prioritize Oversight Activities With a Risk-Based Approach Resulting in a Continual Inspection-Ready State Michael Torok, Ph.D.,Clinical Quality Assurance Head, ASTELLAS |
KEY FINDINGS FROM THE TUFTS CSDD-AVOCA VENDOR QUALIFICATION BENCHMARKING STUDY
|
![]() |
Quantify Vendor Qualification Practices and Experiences and Identify Improvement Opportunities Kenneth A. Getz, MBA,Director of Sponsored Programs, Associate Professor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENTDennis Salotti,Chief Operating Officer, THE AVOCA GROUP |
WORKSHOP: QUALITY TOLERANCE LIMITS
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![]() ![]() |
Demonstrate the Steps for Defining and Implementing Appropriate Quality Tolerance Limits (QTLs) Through Case Study Examples and Hands-On Learning Jonathan Rowe, Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER INC.Stacy St. John, Director, Clinical Development Quality, GCP Quality Management Lead, PFIZER INC. |
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