SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

FDA & MHRA Good Clinical Practices Workshop

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October 23, 2018:

Welcome
David Burrow
Keynote
Robert Temple
Dr. Temple’s Slides
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Session 1 – Data Integrity from International Perspectives
Background and Purpose of Collaboration
Ni Khin
Gail Francis
Slides in ZIP file above
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Quality Management System/Quality by Design (QMS/QbD)
Jean Mulinde
Slides in ZIP file above
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Overview of Data Integrity
Gail Francis
Slides in ZIP file above
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Good Clinical Practice Assessment of Data Reliability in Registration Trials
Kassa Ayalew
Slides in ZIP file above
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Session 2 – Data Management
Control and Quality of Clinical Data
Andy Fisher
Slides in ZIP file above
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The Data Management Plan – Pulling It All Together
Cynthia Kleppinger
Slides in ZIP file above
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Morning Q&A and Panel Discussion was postponed
Morning Speakers
Session 3 – Controlling Bias: The Study Blind
Unblinding – Let Me Count the Ways
Gail Francis
Jean Mulinde
Slides in ZIP file above
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Blinding of Bioequivalence Trials
Seongeun (Julia) Cho
Slides in ZIP file above
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Session 4 – Know Your Audit Trails
Design and Effective Use of Audit Trails
Stephen Vinter
Slides in ZIP file above
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A Case Example of the Review of Audit Trails in GCP Inspections
Phillip Kronstein
Slides in ZIP file above
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Afternoon Q&A and Panel Discussion
Afternoon Speakers
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October 24, 2018:

Day Two of the Workshop consisted of the in-person participants working in small groups on four case studies. It was NOT recorded. However, the materials used for the four case studies can be downloaded here: