India CDISC Day Program
2025 India CDISC Day Program
9:30 - 10:45
Session 1: Opening Ceremony & Welcome
Chair: Tushar Sakpal, Novartis
9:30 - 9:45
Welcome Remarks from the Program Committee
Program Committee Members
9:45 - 10:15
CDISC Vision: Rebuilding Our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President and CEO
10:15 - 10:45
Keynote Presentation
Vicky Poulsen, Standards Director, Novo Nordisk
10:45 - 11:05
Morning Break
11:05 - 12:25
Session 2: CDISC Foundational Standards & RWE
Chair: Gaurab Chakraborty, Veramed
11:05 - 11:25
Population Pharmacokinetics Reporting: Embracing CDISC's New Standard
Shelendra Singh Pawar, Novo Nordisk
11:25 - 11:45
Overcoming Challenges in Pooled SDTM and ADaM Submission: Strategies for Effective Collaboration and Harmonization
Deepthi BM, GSK
11:45 - 12:05
Define-XML v2.1 - Upversioning from 2.0 Experience
Hasna Rabia Mohamed Rafi, Allucent
12:25 - 13:55
Networking Lunch Break
13:55 - 15:15
Session 3: Open Source & Automation
Chair: Linga Reddy Aenugu, Syneos Health
13:55 - 14:15
ADaM.jl: Efficient Dataset Preparation and Reporting tool using Julia
Rajan S Ragav, Pumas-AI/Data Scientist
14:15 - 14:35
Structuring Unstructured Data: A Practical Implementation of ARS
Mouli Nagarajan, Novo Nordisk
14:35 - 14:55
Automation of SDTM using the R package rOAK
Prasanna Parthasarathy, Syneos Health
14:55 - 15:15
TDM Automation
Swetha Rameswaran, Pfizer
15:15 - 15:35
Afternoon Break
15:35 - 16:35
Session 4: Regulatory Submissions
Chair: Kavita Siddayya Math, Novo Nordisk
15:35 - 15:55
Adapting to Regulatory Changes: Insights and Strategies for Successful Submissions
Balaji Muthukrishnan, Cliantha Research Limited
15:55 - 16:15
Collaborating on Standards: An Approach to Harmonizing Vaccine Regulatory Submissions
Arulselvan PK, GSK
16:15 - 16:35
"This or That" Harmonizing Differences between CDISC IG/P21E and FDA/PMDA Submission Expectations
Pratiksha Sunder and Murali Mohana Reddy Kumpati, Eli Lilly
16:35 - 17:30
Session 5: Closing Session
Chair: Deepak Venkataraman, Eli Lilly
16:35 - 17:20
Panel Discussion with CDISC Board of Directors
CDISC Board of Directors
17:20 - 17:30
Closing Remarks / Future of CDISC in India
Program Committee