CRO/Sponsor Summit on Data Integrity in Clinical Research Agenda

Registration

Inauguration

Data Integrity Issues: Root Cause and Practical Solutions
Ravisekhar Kasibhatta, Senior Vice President, Lupin Bioresearch Center, India

Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions
Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd, India

Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions
Shehnaz Vakharia, Managing Director, ADAMAS Consulting APAC, India

Panel Discussion: Data Integrity Issues: Root Cause and Practical Solutions

Coffee Break

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.

Q/A Session

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.

Q/A Session

Clinical Trials: Sponsor and Regulatory Perspectives on Data Integrity
Bapuji Akula, Senior Vice President, Aurobindo Pharma, India

Q/A Session

Lunch Break

Quality Assurance Programme in Clinical Studies
Jayam Ravi, Global Compliance Head, Dr. Reddy's Laboratories Ltd, India

Q/A Session

Quality Assurance Program in Clinical Studies
Ambrish Srivastava, Vice President, Alkem Labs Ltd, India

Q/A Session

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.

Q/A Session

Coffee and End of First Day of Conference

Data Integrity Considerations in Clinical Trials: Looking Beyond "Agency Observations!”
Umesh Banakar, Professor and President, Banakar Consulting Services, United States of America

Q/A Session

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.

Q/A Session

Coffee Break

Recent Expectations on Data Integrity in Bioanalytical Laboratory
Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions, India

Q/A Session

To be Finalized
Prashant Bodhe, Consultant, CliniSearch, India

Q/A Session

Interactive Session - Best Practices for Ensuring Data Integrity

Lunch Break

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

Q/A Session

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?"

Q/A Session

Coffee Break

Data Integrity in Clinical Research: The Journey and the Destination
Amer Alghabban, Vice President, Karyopharm Therapeutics, Switzerland

Q/A Session

Vote of Thanks and Closing Remarks

End of the Conference