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28-30 September 2026
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Agenda for Day Two - Tuesday 29 September, 2026 - CET
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Agenda for Day Two - Tuesday 29 September, 2026 - CET
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Showing 1 of 1 Streams
Networking Break
08:30 - 09:00
Networking Breakfast
Showing 2 of 2 Streams
Regulatory Information Management
Global eSubmissions
09:00 - 09:05
Track Chair’s Review of Day One
- Frits Stulp - Chairman of the Board, CTADHL
09:05 - 09:50
ICH M4 Evolution - The Future of Chemistry, Manufacturing and Controls (CMC) Documentation and Data Quality Standards
- Understand the current status and timeline of ICH M4Q development and what the process will look like by 2028
- Explore the shift from document-centric to data-centric CMC submissions
- Analyse IDMP integration with M4Q
- Learn about data quality specifications and their practical implications
- Manda Pasarkar - Global Regulatory Team Lead, Sanofi
- Laurent Lefebvre - Regulatory CMC Associate Director, Novartis Pharma AG
09:50 - 10:30
The Business Case for an Enterprise-Wide Approach to Data Governance
- Explore how IDMP implementation across non-clinical, clinical and manufacturing functions is driving enterprise-wide data governance
- Connect different data models and interoperability
- Martin Steinmann - Senior Manager, Regulatory Data Strategy, CSL Behring
09:00 - 09:05
Track Chair’s Opening Remarks
09:05 - 09:50
Work Smarter, Submit Faster - AI Powered Document Intelligence Reimagined
- Explore the latest AI applications and use cases in eSubmissions -
- Automated document classification
- Intelligent content extraction
- Predictive quality checks
- Submission readiness assessments
- Discover how machine learning models are reducing manual effort, improving accuracy and accelerating submission timelines while maintaining practicality
- Anastasija Serdega - Analytical Development Scientist, Autolus Therapeutics
09:50 - 10:30
Breaking New Ground - Real-World Data (RWD) Integration in Electronic Regulatory Submissions
- Examine how to effectively integrate RWD into eCTD and other electronic submission formats
- Address data standards, validation requirements, presentation struggles and regulatory expectations across different health authorities
Showing 1 of 1 Streams
Networking Break
10:30 - 11:00
Networking Break
Showing 2 of 2 Streams
Regulatory Information Management
Global eSubmissions
11:00 - 11:45
EU-SRS – ISO IDMP Compliant Substance Database in the European Regulatory System
- Current status of EU-SRS the ISO/IDMP-compliant EU regulators substance database
- Update on Key IDMP implementation challenges and considerations for consistency in ISO IDMP compliant naming and capturing of pharmaceutical substances
- EU-SRS position in the National, European and Global substance data landscape
- Contribution to Global Identifiers and substance management standardisation processes
- Alignment with the M4Q and SPQS efforts for implementing structured data and future perspectives (including cloud based solutions) will be discussed
- Edyta Burda-Daghish - Chemist, BfArM
- Marcel Hoefnagel - Assessor, Biopharmaceuticals, College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)
11:45 - 12:30
IDMP - New European Operating Models
- Learn a concise overview of ISO IDMP and emerging European operating models, including regulator timelines, industry readiness and implications for regulatory submissions and governance
- Understand global identifier and substance-management standards, the current EU-SRS onboarding status, data reconciliation challenges and opportunities for cross-jurisdiction harmonisation
- Isabel Chicharo - Regulatory Data Management Head, European Medicines Agency (EMA)
- Raphael Sergent - Quality Assurance Manager & Senior Pharma Solutions Manager, Accurids
- Ese Aziza - RA Data Strategy & Management Platform Lead, Novartis
- Walid Atai - Business Development Manager, Accurids
11:00 - 11:45
Modular eCTD Strategy – Optimised for Speed and Flexibility
- Explore advanced modular eCTD strategies, including intelligent model reuse and building submission libraries
- Strategies for shared modules across product families
11:45 - 12:30
Understanding Platform Technologies
- Deep dive into protein-based vaccine platforms and their expansion into oncology applications
- Gain comparative insights on human v. veterinary regulatory pathways for platform technologies
- Look into how platform technology regulation will evolve and best practices on preparation
- Maren von Fritschen - Professor, University of Applied Sciences, Berlin
- Jens Pantke - Director Regulatory Digital Innovation & Operations, Moderna
- Mihai Bilanin - Global Regulatory Lead, Vaccines Development, GSK
Showing 1 of 1 Streams
Networking Break
12:30 - 13:30
Networking Luncheon
Showing 2 of 2 Streams
Regulatory Information Management
Global eSubmissions
13:30 - 14:15
Beyond the IDMP Deadline: Why Product Data Only Stays Good if Someone Uses It
Meeting an IDMP remediation deadline can produce a high-quality dataset. It does not keep one. Drawing on eleven expert interviews and anonymized examples from a large pharmaceutical product data programme, this session examines a recurring pattern: data used by critical business processes gets corrected, while data structured only for compliance quietly drifts. Examples cover canonical models, golden records and stewardship. Attendees will leave with a way to assess their own IDMP data.
- Matthias Sijtstra - Senior Consultant, MAIN5
14:15 - 15:00
System Maturity in RIM - What Does it Really Mean?
- Reframe your perspective of RIM maturity as people and behavior driven and not just a technology metric
- Glean practical steps to align teams, processes and tools to foster sustainable system maturity
- Hear clear, actionable indicators to track progress and close the adoption gap
- Sabeeh Habib-Ullah - Associate Manager Regulatory Information Management, Regeneron
13:30 - 14:15
Digital Regulatory Pathways: From Regulatory Signals to the Box in the User's Hands - Building an eLabelling Platform for Today's Reality and Tomorrow's Regulations
- Explore the strategic need for e-Portals and e-Labeling to reduce paper reliance, streamline promotional material updates and simplify global ad revisions
- Hear practical considerations, common roadblocks and collaboration strategies with local partners when building e-Labeling and e-Submissions platforms in emerging markets
- Compare regional deployment approaches and outline high-level strategies for implementing e-Portals across the EU, APAC and beyond
- Jianhui Zheng - Regulatory Affairs Senior Manager, Septodont
- Kimty Bui-Van - Global Vice President Regulatory Affairs, Septodont
14:15 - 15:00
Post-Approval Change Management in the Digital Age - eSubmissions Strategies
- Glean modern approaches to variations, supplements and change notifications across global markets - streamline post-approval lifecycle management
- Strategies for grouping and sequencing post-approval submissions
- Digital tools for tracking submission status and regulatory commitments
- Olga Braem - Director, Global Regulatory Affairs CMC, Kyowo Kirin
Showing 1 of 1 Streams
Networking Break
15:00 - 15:30
Networking Break
Roundtable Strategy Sessions
Showing 3 of 3 Streams
Breakout Session 1
Breakout Session 2
Breakout Session 3
15:30 - 17:00
RIM Data Cleansing -Addressing the Mess in Your Regulatory Information Management System
This interactive roundtable brings together regulatory operations professionals who are actively engaged in RIM data cleansing. Share practical experiences and strategies to leave with actionable approaches to address your data quality challenges.
- Claudia Stump - Business Systems Manager, R&D Information and Services – Regulatory Systems and Operations, Daiichi Sankyo
- Christine Kavanaugh - Manager Regulatory Information Management & Innovation, Regeneron
15:30 - 17:00
AI-Driven Regulatory Operations: Practical Adoption & Data Foundations
- Identify pragmatic AI use cases relevant to regulatory workflows and RIM
- Clarify the data integration and semantic alignment requirements needed for AI to perform reliably in regulatory contexts
- Define governance, stewardship and validation guardrails to maintain long-term data quality and compliant AI use
15:30 - 17:00
IDMP Readiness - Practical Implementation Strategies
IDMP isn’t just a regulatory checkbox - it's a fundamental transformation of how you structure, manage and exchange product information. This roundtable brings together regulatory operations professionals, data managers and IDMP implementation leaders who are in the trenches.
- Patrick Middag - Principal Regulatory Affairs Lead, HRIM Program, Servier
- Toni Isaacs - Data Governance, Standards & Quality – XEVMPD/IDMP, GSK
Showing 1 of 1 Streams
Networking Break
17:00 - 17:05
End of Day 2
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