Draft Agenda (Subject to Change) | ||||
08:00 | Registration | |||
09:30 | Inauguration | |||
09:50 |
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10:16 | Data Integrity Issues: Root Cause and Practical Solutions | |||
10:16 | Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions | |||
10:16 | Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions | |||
10:16 | Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions | |||
10:45 | Coffee Break | |||
11:15 | The Data Integrity Journey in Clinical Trials from Sponsor Perspective | |||
11:55 | Q/A Session | |||
12:00 | Sponsors' Perspective on Data Integrity | |||
12:40 | Q/A Session | |||
12:45 | Clinical Trials: Sponsor and Regulatory Perspectives on Data Integrity | |||
13:25 | Q/A Session | |||
13:30 | Lunch Break | |||
14:30 | Quality Assurance Programme in Clinical Studies | |||
15:10 | Q/A Session | |||
15:15 | Quality Assurance Program in Clinical Studies | |||
15:55 | Q/A Session | |||
16:00 | Challenges of GCP Compliance : Human Protection and Data Integrity | |||
16:40 | Q/A Session | |||
16:45 | Coffee and End of First Day of Conference |
09:30 | Data Integrity Considerations in Clinical Trials: Looking Beyond "Agency Observations!” | |
10:10 | Q/A Session | |
10:15 | Management of Regulatory Inspections | |
10:55 | Q/A Session | |
11:00 | Coffee Break | |
11:30 | Recent Expectations on Data Integrity in Bioanalytical Laboratory | |
12:10 | Q/A Session | |
12:15 | To be Finalized | |
12:55 | Q/A Session | |
13:00 | Interactive Session - Best Practices for Ensuring Data Integrity | |
13:30 | Lunch Break | |
14:30 | Expectations and Updated Guidance on BE and Data integrity: A Perspective from the WHO Prequalification Team | |
15:10 | Q/A Session | |
15:15 | Risk Mitigation Programme in CRO | |
15:55 | Q/A Session | |
16:00 | Coffee Break | |
16:15 | Data Integrity in Clinical Research: The Journey and the Destination | |
16:55 | Q/A Session | |
17:00 | Vote of Thanks and Closing Remarks | |
17:05 | End of the Conference |