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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 3: Inspection Readiness: Different Approaches to Inspection Readiness with Real-World Case Studies and Inspection Outcomes from Sponsors

Session Chair(s)

Jamie  O'Keefe

Jamie O'Keefe

Head, Clinical & Regulatory Consulting

Astrix, United States

Discussion on the approaches to inspection readiness with real-world case studies and inspection outcomes from sponsors. We will discuss different approaches to study level inspection readiness:

  • Reactive: Based upon an anticipation of an audit or audit request, performing IR reviews, identifying gaps and issues, and taking a risk based approach to remediation and storyboarding
  • Pro-active: Establishing Inspection Readiness processes and a culture of inspection readiness throughout clinical trial management, and implementing across all studies
  • Hybrid: Based upon an understanding that certain programs are not inspection ready, execute an IR review program, and leverage the findings to not only remediate the specific programs, but establish new processes and culture across the portfolio

Learning Objective : At the conclusion of this session, participants should be able to:
  • Define Inspection Readiness
  • Compare and contrast the pros and cons of different approaches to Inspection Readiness
  • Choose the best approach for your organization

Speaker(s)

Donna  Dorozinsky, BSN, MSN

Speaker

Donna Dorozinsky, BSN, MSN

Just in Time GCP, United States

President & CEO

Jaclyn  Verrow

Speaker

Jaclyn Verrow

Vertex Pharmaceuticals, United States

Director, Clinical Quality Management

Gabriela  Stanescu, RN

Speaker

Gabriela Stanescu, RN

Chiesi Canada Corporation, Canada

Lead Clinical Project Manager

Jamie  Toth, MS

Speaker

Jamie Toth, MS

Beigene, United States

Global Head, TMF Management & Records

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