Download the Agenda – Speaker’s Bios
October 23, 2018:
| Welcome David Burrow Keynote Robert Temple |
Dr. Temple’s Slides View Recording |
| Session 1 – Data Integrity from International Perspectives | |
| Background and Purpose of Collaboration Ni Khin Gail Francis |
Slides in ZIP file above View Recording |
| Quality Management System/Quality by Design (QMS/QbD) Jean Mulinde |
Slides in ZIP file above View Recording |
| Overview of Data Integrity Gail Francis |
Slides in ZIP file above View Recording |
| Good Clinical Practice Assessment of Data Reliability in Registration Trials Kassa Ayalew |
Slides in ZIP file above View Recording |
| Session 2 – Data Management | |
| Control and Quality of Clinical Data Andy Fisher |
Slides in ZIP file above View Recording |
| The Data Management Plan – Pulling It All Together Cynthia Kleppinger |
Slides in ZIP file above View Recording |
| Morning Q&A and Panel Discussion was postponed Morning Speakers |
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| Session 3 – Controlling Bias: The Study Blind | |
| Unblinding – Let Me Count the Ways Gail Francis Jean Mulinde |
Slides in ZIP file above View Recording |
| Blinding of Bioequivalence Trials Seongeun (Julia) Cho |
Slides in ZIP file above View Recording |
| Session 4 – Know Your Audit Trails | |
| Design and Effective Use of Audit Trails Stephen Vinter |
Slides in ZIP file above View Recording |
| A Case Example of the Review of Audit Trails in GCP Inspections Phillip Kronstein |
Slides in ZIP file above View Recording |
| Afternoon Q&A and Panel Discussion Afternoon Speakers |
View Recording |
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:
- Case Study 1: Vendor Selection
- Case Study 2: Unblinding
- Case Study 3: Audit Trail
- Case Study 4: Data Management