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Session 7, Track 1: Data-driven Submissions - How Pharmaceutical Companies are Getting Ready for a New Era
Session Chair(s)
Venkatraman Balasubramanian, MBA
Healthcare and Life Sciences Strategic Advisor, VB Insights, LLC, United States
As regulatory agencies implement structured, modular, and digital-first requirements, leading pharmaceutical organizations are confronting unprecedented regulatory convergence. Initiatives such as ICH M4Q(R2), CDISC USDM, ICH M11, and ePI are reshaping content creation, more as data, across clinical, CMC, and labeling domains—demanding both operational and organizational transformation. This session will have transformation leaders from multiple pharmaceutical companies and providers to share how they are designing future-state operating models, building scalable governance for cross-functional content collaboration, sequencing technology implementation for maximum impact, and overcoming organizational resistance to digital transformation. Attendees will hear from organizations at varying stages of adoption, from early pilots to mature programs. This collaborative session provides actionable strategies for pharmaceutical leaders building comprehensive digital content ecosystems that position their organizations for regulatory modernization initiatives including FDA KASA requirements, EMA SPOR implementation, and emerging global harmonization standards driving the future of pharmaceutical operations. Speakers will share practical insights on establishing Centers of Excellence, managing change across regulatory affairs, clinical operations, and manufacturing quality teams, while addressing technical challenges including enterprise system integration and metadata standardization.
Data-driven Submissions from a Labeling Perspective
Niklas Jaenich, Boehringer Ingelheim
Clinical Data Driven Submissions: Human-Data Partnership
Madhavi Gidh-Jain, Sanofi
CMC - ICH Structured Product Quality Submissions
Laurent Lefebvre, Novartis
Structured, Governed, Reusable: Moving Beyond Static Documents to Data-Centric Velocity Murali Menon, Docuvera
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand How Leading Pharma Companies Are Implementing Structured Content Strategies to Improve Regulatory Agility
- Gain Practical Strategies for Building Scalable Governance and Future-State Operating Models
- Explore How to Overcome Organization Resistance and Enable Digital Transformation Through Effective Change Management and System Integration
Speaker(s)
Niklas Jaenich, PhD, RPh
Head of Global Labeling Operations and Digitization, Boehringer Ingelheim, Germany
Data-driven Submissions from a Labeling Perspective
Madhavi Gidh-Jain, PhD
Global Head of Medical Writing and Document Management, Sanofi US, United States
Clinical Data Driven Submissions: Human-Data Partnership
Laurent Lefebvre, PharmD, MPharm
Head RA Data & Technology, Novartis, Switzerland
CMC - ICH Structured Product Quality Submissions
Murali Menon, MS
CRO, Docuvera, United States
Structured, Governed, Reusable: Moving Beyond Static Documents to Data-Centric Velocity
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