Thursday, 21 July 2016 |
Conference Agenda |
| | 08:00 | Registration | 09:00 | Welcome Address | |
Session I: Ensuring Successful BA/BE Studies in Light of Regulatory Requirements |
| | 09:20 |  | Keynote Presentation Clinical Phase I – BA/BE Investigation: Data Generation and Integrity Considerations
Umesh Banakar, Professor and President, Banakar Consulting Services, United States of America
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| 10:05 | Q/A Session | 10:10 | Quality and Data Integrity in BE Trials: The Prequalification Paradigm
Anders Fuglsang, Consultant and Founder, Fuglsang Pharma, Denmark
| 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
Bhaswat Chakraborty, Senior Vice President & Chairman, Cadila Pharmaceuticals, India
| 11:50 | Q/A Session | 11:55 | CRO Audits-Vital Requirements & Audit Points - Managing Unannounced Audits
K Umamaheshwar, Chief Executive , AET Clinical Services Pvt Ltd, India
| 12:30 | Q/A Session | 12:35 | Open Discussion Session 1 | 12:50 | Lunch Break and Networking in Exhibition Area | 13:50 |  | Keynote Presentation Recent Updates to WHO Guidelines
Stephanie Croft, Technical Officer Inspector, World Health Organization, Switzerland
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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
Ravisekhar Kasibhatta, Senior Vice President, Lupin Bioresearch Center, India
| 15:05 | Q/A Session | 15:10 | CRO/Sponsor - Bridging Gaps - Roles, Responsibilities, BE-NOC Approvals
Saral Thangam, Managing Director & CEO, Norwich Clinical Service, India
| 15:45 | Q/A Session | 15:50 | CRO/Sponsor - Bridging Gaps - Elements of Master Service Agreement
K Senthilkumar, Chief Executive Officer, Spinos Life Science and Research Pvt Ltd, India
| 16:25 | Q/A Session | 16:30 | Open Discussion Session 2 | 17:00 | End of First Day of Conference |
Friday, 22 July 201609:30 | Clinical Trials for Biological Products
C N Ramchand, Chief Executive Officer, Saksin Lifesciences Pvt Ltd, India
| 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
Bodo Lutz, Data Integrity Officer, Novartis, Germany
| 11:25 | Q/A Session | 11:30 | Ensuring Data Integrity in Clinical Study - Significance, Issues and Challenges
Arani Chatterjee, Senior Vice President, Biological E Limited, India
| 12:05 | Q/A Session | 12:10 | Data Integrity Concepts in Clinical Trials
Chandra Sekhar, Vice President Quality, Reliance Life Sciences, India
| 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
Prashant Bodhe, Consultant, CliniSearch, India
| 14:40 | Q/A Session | 14:45 | IT Security and Data Privacy in Global Trials from an EU Perspective
Marc E Brooks, Chief Executive Officer, Elderbrook Solutions GmbH, Germany
| 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
Rajendra M Prasad, Chief Executive Officer & Executive Director, Jeevan Scientific Technology Limited, India
| 16:15 | Q/A Session | 16:20 |  Company Presentation
Nupur Goel, Business Development Manager, Micro Therapeutic Research Labs Pvt Ltd
| 16:40 | Panel Discussion: Brexit - Impact on UK and EU Drug Regulations
| 17:30 | Closing Remarks and Vote of Thanks |
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