WCG FDAnews Announces the Clinical Trials Track at the 17th Annual FDA Inspections Summit, Nov. 16-18, 2022, Washington, DC

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FDA and industry VIPs share must-know inspection information in the Clinical Trials track at the 17th Annual FDA Inspections Summit.

17th Annual FDA Inspections Summit
**Presented by WCG FDAnews**
Nov. 16-18, 2022 • Washington, DC
Inspections Summit (11/16-18) Clinical Trials Track

The Clinical Trials track at the 17th Annual FDA Inspections Summit has been carefully crafted to provide everything clinical trials professionals need to ensure inspection success.

FDA and clinical trial industry VIPs will lead every session and workshop will help attendees pass future inspections, no matter their current challenges.

The event begins with Elizabeth Miller, Pharm.D., assistant commissioner for medical products and tobacco operations in the Office of Regulatory Affairs at the FDA. She’ll discuss the latest plans and initiatives coming out of the agency so attendees can prepare for what’s to come in FDA inspections, whether on-site or virtual.

Members of the WCG Avoca Quality Consortium (AQC) will be a constant presence in the Clinical Trials track, guiding the sessions to help participants understand:

  • Purpose-Driven Inspection Preparedness: People, Process and Technology — Critical Components to Success

This panel will connect, collaborate, and explore how building quality relationships, planning processes proactively, and using current technology solutions brings inspection success in an environment where clinical trial professionals are often doing more with less. Panelists include Téa Romero, client success manager at Clario; Neala Lane, associate director, Quality Improvement Office at Indiana University; Trevor Cole, senior manager at WCG; and Gary Shorter, senior director of emerging technology and AI at IQVIA Tech.

  • The Potential — and Limitations — of Technology-Driven TMF Compliance

TMF-readiness is and will remain a key focus for inspections and a key pain point for sponsors and CROs. Can artificial intelligence and machine learning (AI/ML) or other automation fill this gap? This discussion addresses the promise and challenges associated with applying these approaches in a validated environment. Presented by Ted Finlan, senior vice president for project planning and administration at Worldwide Clinical Trials.

  • BIMO in Action: WCG AQC Members Share Insights from Their Recent Inspection Experiences    

This session will review significant updates to the Bioresearch Monitoring Program (BIMO) / Sponsors and Contract Research Organizations Program released in September 2021 and share feedback from members’ inspection experiences. Presented by Karen Harvey, senior director of the WCG Avoca Quality Consortium.

  • And hear directly from the FDA!

Engage in a session on validating systems and equipment for compliance with the FDA’s Francisco Vicenty, program manager, Case for Quality, and Daniel Walter, policy analyst. Attendees will have the opportunity to participate in a mock inspection with Simone Pitts (invited), FDA national expert, pharmaceutical.

This level of FDA and industry expertise with this combination of must-know topics can only be found at the 17th Annual FDA Inspections Summit’s Clinical Trials track.

Conference Details
17th Annual FDA Inspections Summit
**Presented by WCG FDAnews**
Nov. 16-18, 2022 • Washington, DC

Complete Summit $1,997
Additional pricing and livestreaming options are available online.

Easy Ways to Register:
Online: https://wcg.swoogo.com/fda-inspections-summit-2022
By phone: 888-838-5578 or 703-538-7600

About WCG FDAnews:
WCG FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on WCG FDAnews' newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations. Learn more at fdanews.com.

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Michelle Butler
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