Thursday, 2 March 2017 | Draft Agenda (Subject to Change) |
| | 08:00 | Registration | 09:30 | Inauguration | 09:50 | | Guest of Honour Opening Talk K Bangarurajan, Deputy Drugs Controller, Central Drugs Standard Control Organisation (CDSCO), India
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| 10:16 | Data Integrity Issues: Root Cause and Practical Solutions Ravisekhar Kasibhatta, Senior Vice President, Lupin Bioresearch Center, India
| 10:16 | Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd, India
| 10:16 | Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions Shehnaz Vakharia, Managing Director, ADAMAS Consulting APAC, India
| 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 Diego Herrera, Head of Global Data Management and Project Information, Almirall S.A., Spain
This presentation will explain how to mitigate data integrity risks in clinical trials, explore common issues, and what preventive actions need to be taken to minimize the impact of the current complexity, from the data source to final clinical study report. | 11:55 | Q/A Session | 12:00 | Sponsors' Perspective on Data Integrity Bodo Lutz, Data Integrity Officer, Novartis, Germany
Non-compliances published by the European Medicines Agency (EMA) or warning letters from FDA show examples from companies all over the world. This presentation will show potential initiatives which can support the detection and/or mitigation of Data Integrity risks as: educating and training of personnel, Risk Management, Technology and IT Systems and Governance of Data Integrity. | 12:40 | Q/A Session | 12:45 | Clinical Trials: Sponsor and Regulatory Perspectives on Data Integrity Bapuji Akula, Senior Vice President, Aurobindo Pharma, India
| 13:25 | Q/A Session | 13:30 | Lunch Break | 14:30 | Quality Assurance Programme in Clinical Studies Jayam Ravi, Global Compliance Head, Dr. Reddy's Laboratories Ltd, India
| 15:10 | Q/A Session | 15:15 | Quality Assurance Program in Clinical Studies Ambrish Srivastava, Vice President, Alkem Labs Ltd, India
| 15:55 | Q/A Session | 16:00 | Challenges of GCP Compliance : Human Protection and Data Integrity Arun Bhatt, Consultant, Clinical Research & Development, India
This talk will discuss how to boost quality of clinical trial conduct and to improve compliance to GCP standards. | 16:40 | Q/A Session | 16:45 | Coffee and End of First Day of Conference |
Friday, 3 March 201709:30 | Data Integrity Considerations in Clinical Trials: Looking Beyond "Agency Observations!” Umesh Banakar, Professor and President, Banakar Consulting Services, United States of America
| 10:10 | Q/A Session | 10:15 | Management of Regulatory Inspections Chitra Bargaje, Principal Consultant, ADAMAS Clinical Quality Consulting Pvt Ltd, India
This presentation would focus on the strategies to be implemented before, during and after inspection to ensure effective management of regulatory inspections. | 10:55 | Q/A Session | 11:00 | Coffee Break | 11:30 | Recent Expectations on Data Integrity in Bioanalytical Laboratory Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions, India
| 12:10 | Q/A Session | 12:15 | To be Finalized Prashant Bodhe, Consultant, CliniSearch, India
| 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 Stephanie Croft, Technical Officer Inspector, World Health Organization, Switzerland
| 15:10 | Q/A Session | 15:15 | Risk Mitigation Programme in CRO Prashant Pandya, General Manager, Reliance Life Sciences Pvt Ltd, India
This talk will describe various risk mitigation strategy useful for CROs with an analysis of potential liabilities and establishes steps that may help minimize these and will also focus on some case Studies which would explain "How to identify issues, reduce risk and improve overall quality and compliance" and "What strategies should be adopted to enable risk-based monitoring approach?" | 15:55 | Q/A Session | 16:00 | Coffee Break | 16:15 | Data Integrity in Clinical Research: The Journey and the Destination Amer Alghabban, Vice President, Karyopharm Therapeutics, Switzerland
| 16:55 | Q/A Session | 17:00 | Vote of Thanks and Closing Remarks | 17:05 | End of the Conference |
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