10th Clinical Quality Oversight Forum – 9th 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
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 DEVELOPMENT
Dennis Salotti,
Chief Operating Officer,
THE AVOCA GROUP
WORKSHOP: QUALITY TOLERANCE LIMITS
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.
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

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
Startdate:
End Date

Description: The Clinical Quality Oversight Forum provides risk-based approaches for selecting, managing and monitoring clinical vendors and sites.
Performer: ExL Events
Address : 10th Clinical Quality Oversight Forum


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Testimonials

  • "The Clinical Quality Oversight Forum in October was EXCELLENT! This was my first time attending an ExL event and I was very happy with my experience. The content was well presented, the presenters were engaging and everything was just so organized and well done. What I liked most was that the level of the content was meant for moderate to highly experienced individuals in QA — it's often hard to find something that isn't just an 'intro to QA.' I am looking forward to attending more ExL events in the future.”

    —Senior Associate, Clinical Quality Assurance, EISAI INC.

  • "My compliments to the entire ExL Pharma Team for how you operate. You have a well-oiled operation. Everyone has a positive 'can-do;' attitude. The entire experience was extremely positive and I can’t thank you enough!”

    —Director, Global Pharma R&D Sourcing, Cardiovascular & Metabolism, JANSSEN RESEARCH & DEVELOPMENT, LLC

  • "I’ve had the privilege of participating in and presenting at several ExL Pharma conferences in the U.S. and Europe. This company arranges some of the best-organized and informative industry conferences in my experience. Topics are relevant, presenters are engaged, and the mix of presentation/panel/discussion strikes the right balance for effective education. In addition, the people at ExL Pharma are truly professional in their development and execution of these important events.”

    —Senior Director, Oncology Field Operations, SANOFI-AVENTIS

  • "This was an excellent conference — very informative and useful.”

    —Compliance Advice and Assurance Advisor, ASTRAZENECA

  • "The conference and speakers were all excellent. This was a very valuable conference and input from the participants will improve our quality oversight of vendors.”

    —Auditor, Quality Assurance, INFINITY PHARMACEUTICALS

  • "This was one of the best I’ve attended in a long while. Interactions were excellent.”

    —Senior Director, QA, ICON

  • "Excellent. Well worth the time attending. Great representation from industry for speakers — not the same-old crowd.”

    —Director, Outsourcing and Contracts, GENZYME

  • "Conference was a positive open forum that provided an opportunity for sponsors and vendors to come together and share experiences, lessons learned, and identify a path to improve sponsor oversight through better channels of communication”

    —Associate Director, Global R&D Quality Assurance, SHIRE PHARMACEUTICALS

  • "Exceeded expectations. Excellent conference with excellent speakers. All of us learned a lot and conferences like these are what improve the drug development process.”

    —Managing Director, GLOBAL DRUG DEVELOPMENT EXPERTS