Clinical Research Quality-Impact of Digitalization & Innovation
  • Day1
  • Day2
Thursday, 2nd September 2021

13:00

Test Run and Web Checks

13:30

Workshop: Portfolio Enhancement & Product Rationalization (Dr Avijit Kelkar)

14:30

Welcome Address and Introduction to the Experts
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India

14:49

Session 1: Virtual Meetings & Trial Monitoring

14:50

Virtual Meetings and Trial Monitoring
Ravi Sekhar Kasibhatta, Senior Vice President, Lupin Ltd, India

15:15

Virtual Meetings and Trial Monitoring- Investigators Meetings, Site Selection and Monitoring
Ashish Mungantiwar, Executive President – Medical Services, Macleods Pharmaceuticals Limited, India

15:40

Comments, Issues and Experiences - Presentation by the Participants

15:50

Panel Discussion - Lead Experts - Dr Ravi Sekhar Kasibhatta and Dr Ashish Mungantiwar

16:09

Session 2: Patient Recruitment, Retention & Engagement

16:10

Patient Recruitment, Retention & Engagement - Patient Recruitment - Issues and Solutions, Improving Patient Engagement & Experience
Melva T Covington, Senior Vice President, Curio Digital Therapeutics, Inc., USA

16:35

Patient Recruitment, Retention & Engagement - Patient Recruitment - Issues and Solutions, Improving Patient Engagement & Experience
Rasmus Hogreffe, Vice President - Decentralized Clinical Trial Innovation, Medable Inc, USA

17:00

Comments, Issues and Experiences - Presentation by the Participants

17:10

Panel Discussion - Lead Experts - Dr Melva T Covington and Dr Rasmus Hogreffe

17:30

End of First Day of meeting

Friday, 3rd September 2021

14:30

Recap and Introduction of Day 2 Experts

14:34

Session 3: Clinical Trial Design & Data

14:35

Real-world Data - Potential in Clinical Research, Challenges in Reusing Clinical Data
Anupama Ramkumar, Principal Consultant & CEO, Arkus Research Pvt. Ltd., India

15:00

Innovative Approaches for Patient Retention and Engagement in a Multinational Clinical Trials Experience using Integrated Data Collection Platform
Diego Herrera, Head of Global Data Management and Information Mangement, Almirall S.A., Spain

15:25

Comments, Issues and Experiences - Presentation by the Participants

15:30

Panel Discussion - Lead Experts - Dr Diego Herrera and Dr Anupama Ramkumar

15:49

Session 4: Outsourcing Risks and Management

15:50

Outsourcing Risks and Management - Partnership, Tracking & Management, Risk-based Approaches, and Monitoring
Charles Mueller, Head of Clinical & Bioanalytical Quality, Viatris, USA

16:15

The impact of new guidance\'s (ICH E6 R2/R3 and ICH E8 R1) on Outsourcing
Andy Lawton, Consultant, Risk Based Approach Ltd, United Kingdom

16:40

Resistance Management in Clinical Research Digital Transformation
Erika Stevens, MA, Principal, Recherche Transformation Rapide, USA

17:05

Comments, Issues and Experiences - Presentation by the Participants

17:10

Panel Discussion - Lead Experts - Dr Andy Lawton, Dr Charles Mueller and Ms Erika Stevens

17:30

Closing Remarks and End of the meeting

17:35

Networking in Lounge (Available only after the end of session)

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