Agenda

Welcome Address

Introduction of resource persons

Quality Management Systems: Minding the P’s and the Q’s!
Anupama Ramkumar, Principal Consultant & CEO, Arkus Research Pvt. Ltd., India

Q/A Session

Quality-By-Design: Bioequivalence Perspective
Raghavendra Pai, Chief-Quality Assurance & Compliance, Norwich Clinical Services - CRO, India

Q/A Session

Designing Quality in Clinical Trials: A Quality by Design Approach
William Andrew Lawton, Consultant, Risk Based Approach Ltd, United Kingdom

Q/A Session

Prevention versus Correction: Effective Adoption of Comprehensive Quality Management
Kevin Robinson, Executive Director, Clinical Quality Assurance, GSK, United Kingdom

Q/A Session

Clinical Trial Design: Appropriate Methods for Decentralization or Incorporation of Diversity
Blake Wilson, Partner (FDA Regulatory), Hogan Lovells, US

Q/A Session

Technology-enabled Clinical Trials: Data Types, Operating Models, and Enabling Risk-Based Approaches
Todd Georgieff, Consultant, Futurpositif - Digital Clinical Trials Consulting, US

Q/A Session

Panel Discussion: Navigating the Regulatory Landscape: Strategies for Sponsors and Investigators to Ensure Compliance and Ethical Practice- By Dr. Annam Visala (CDSCO)

Panel Discussion: Navigating the Regulatory Landscape: Strategies for Sponsors and Investigators to Ensure Compliance and Ethical Practice- By Anuradha Dahanayaka (RemediumOne Pvt Ltd)

Panel Discussion: Navigating the Regulatory Landscape: Strategies for Sponsors and Investigators to Ensure Compliance and Ethical Practice- By Dr. Ashish Mungantiwar (Macleods Pharmaceuticals Ltd)

Vote of Thanks