Conference Agenda | ||||
08:00 | Registration | |||
09:00 | Welcome Address | |||
Session I: Ensuring Successful BA/BE Studies in Light of Regulatory Requirements | ||||
09:20 |
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10:05 | Q/A Session | |||
10:10 | Quality and Data Integrity in BE Trials: The Prequalification Paradigm | |||
10:45 | Q/A Session | |||
10:50 | Coffee Break and Networking in Exhibition Area | |||
Session II: CRO Audits-Vital Requirements & Audit Points | ||||
11:15 | Developing Protocols and Procedures for Clinical Trial Data Integrity | |||
11:50 | Q/A Session | |||
11:55 | CRO Audits-Vital Requirements & Audit Points - Managing Unannounced Audits | |||
12:30 | Q/A Session | |||
12:35 | Open Discussion Session 1 | |||
12:50 | Lunch Break and Networking in Exhibition Area | |||
13:50 |
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14:15 | Q/A Session | |||
Session III: CRO/Sponsor - Bridging Gaps | ||||
14:30 | "Data Integrity in Clinical Research – Quadruple Face-off” – A Sponsor Perspective | |||
15:05 | Q/A Session | |||
15:10 | CRO/Sponsor - Bridging Gaps - Roles, Responsibilities, BE-NOC Approvals | |||
15:45 | Q/A Session | |||
15:50 | CRO/Sponsor - Bridging Gaps - Elements of Master Service Agreement | |||
16:25 | Q/A Session | |||
16:30 | Open Discussion Session 2 | |||
17:00 | End of First Day of Conference |
09:30 | Clinical Trials for Biological Products | |
10:15 | Q/A Session | |
10:20 | Coffee Break and Networking in Exhibition Area | |
Session IV: Ensuring Data Integrity in Clinical Study | ||
10:50 | Data Integrity – Approach in Clinical Research | |
11:25 | Q/A Session | |
11:30 | Ensuring Data Integrity in Clinical Study - Significance, Issues and Challenges | |
12:05 | Q/A Session | |
12:10 | Data Integrity Concepts in Clinical Trials | |
12:45 | Q/A Session | |
12:50 | Open Discussion Session 3 | |
13:05 | Lunch Break and Networking in Exhibition Area | |
Session V: Compliance & IT Security in Global Trials | ||
14:05 | Data Integrity: Compliance Paradigms | |
14:40 | Q/A Session | |
14:45 | IT Security and Data Privacy in Global Trials from an EU Perspective | |
15:20 | Q/A Session | |
15:25 | Coffee Break and Networking in Exhibition Area | |
Session VI: Indian CRO - Challenges & Solutions | ||
15:40 | Indian CRO - Issues, Challenges and Possible Solutions - Regaining and Retaining Integrity | |
16:15 | Q/A Session | |
16:20 | Company Presentation | |
16:40 | Panel Discussion: Brexit - Impact on UK and EU Drug Regulations | |
17:30 | Closing Remarks and Vote of Thanks |