India CDISC Day Presentation Archive
Thank you for attending CDISC 2025 India Day!
We appreciate your participation and look forward to welcoming you again in 2026.
Session 1: Opening Ceremony & Welcome
Chair: Tushar Sakpal, Novartis
Safety Briefing
EHSS Head
Welcome Remarks from the Program Committee
Program Committee Members
CDISC Vision: Rebuilding Our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President and CEO
Keynote Presentation: Operationalising CDISC Standards
Vicky Poulsen, Standards Director, Novo Nordisk
Morning Break
Session 2: CDISC Foundational Standards & RWE
Chair: Gaurab Chakraborty, Veramed
Population Pharmacokinetics Reporting: Embracing CDISC's New Standard
Shelendra Singh Pawar, Novo Nordisk
Overcoming Challenges in Pooled SDTM and ADaM Submission: Strategies for Effective Collaboration and Harmonization
Deepthi BM and Jyothi Atmakuri, GSK
Define-XML v2.1 - Upversioning from 2.0 Experience
Husna Rabia Mohamed Rafi, Allucent
Real-World Evidence (RWE) In Clinical Research: Benefits, Challenges, and Strategies for Success
Karthik A.N., IQVIA
Networking Lunch Break
Session 3: Open Source & Automation
Chair: Linga Reddy Aenugu, Syneos Health
ADaM.jl: Pharmacokinetic Dataset Preparation and Reporting tool using Julia
Ragav Rajan S, Pumas-AI/Data Scientist
Structuring Unstructured Data: A Practical Implementation of ARS
Mouli Nagarajan, Novo Nordisk
Modular programming of SDTM in R using {sdtm.oak}
Prasanna Parthasarathy, Syneos Health
TDM Automation
Swetha Rameswaran, Pfizer
Afternoon Break
Session 4: Regulatory Submissions
Chair: Kavita Siddayya Math, Novo Nordisk
Adapting to Regulatory Changes: Insights and Strategies for Successful Submissions
Yash Patel, Cliantha Research Limited
Collaborating on Standards: An Approach to Harmonizing Vaccine Regulatory Submissions
Arulselvan PK, GSK
"This or That" Harmonizing Differences between CDISC IG/P21E Guidelines and FDA/PMDA Submission Expectations
Pratiksha Sunder, Eli Lilly and Company
Session 5: Closing Session
Chair: Deepak Venkataraman, Eli Lilly
Panel Discussion with CDISC Board of Directors
Moderator: Abhijit Roy, Eli Lilly
Closing Remarks / Future of CDISC in India