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28-30 September 2026
Radisson Brussels Grand PlaceBrusselskeyboard_arrow_right
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Agenda for Day Three - Wednesday 30 September, 2026 - CET
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Agenda for Day Three - Wednesday 30 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 - 09:10
Track Chair’s Review of Day Two
- Christian Hay - Chair, ISO - International Organization for Standardization
09:10 - 09:40
Master Data Management - Building the Foundation for Digital Regulatory Operations
- Learn practical approaches to MDM team structures, looking into team structure for effective data management
- Hear proven strategies for data transformation without disruption
- Assess real-world applications of AI in data management
- Explore day-to-day data governance frameworks with clear roles, responsibilities and processes
- Filip Cvetanovski - Regulatory Operations Officer, ALKALOID AD Skopje
- Luisa Heesen - Business Domain Owner Product and Substance, Boehringer Ingelheim
09:40 - 10:15
Making Global IDMP Identifiers Work in Practice – Enabling Adoption in Pharmacovigilance and Cross-Border Healthcare
Participants will learn how global ISO IDMP identifiers are being operationalised through the Global PhPID Service and integrated into existing pharmacovigilance and regulatory ecosystems. The session will demonstrate how regulators and healthcare stakeholders can leverage global identifiers to improve interoperability, strengthen pharmacovigilance, and support cross-border healthcare without replacing existing national systems.
- Marilina Castellano - Product Manager, Uppsala Monitoring Centre (UMC)
09:00 - 09:10
Track Chair’s Review of Day Two
- Torkil Fredborg - Associate Vice President, Head of Global Regulatory Delivery and Excellence, Eli Lilly
09:10 - 09:40
Electronic Product Information (ePI) – From Regulatory Requirement to Digital Health Enabler
- Understand the latest EMA and EU timelines, requirements and practical steps for ePI implementation
- Conduct readiness assessment of your organization’s current state v. ePI and eCTD 4.0 requirements
- Align ePI with IDMP/SPOR and PMS to enable structured data, interoperability and reduced rework
- Adopt governance, operating models and KPIs to scale ePI as part of digital health and patient information strategies
- Elisabeth Fleck - Project Officer, electronic product information (ePI) project, European Medicines Agency (EMA)
09:40 - 10:15
AI in Global eSubmissions – From Data Chaos to Intelligent Automation
- Learn how to best utilise AI as your best asset to navigate, automate and transform your data integration processes
- Cut through the AI industry discussion and understand the data integration foundation required to make AI work and how to build it without disrupting your current operations
- Establish semantic alignment strategies that enable AI to understand your data
- Jimita Parekh - Vice President, Regulatory Technology & Innovation, DNAnexus
Showing 1 of 1 Streams
Networking Break
10:15 - 10:45
Networking Break
Showing 1 of 1 Streams
General Session
10:45 - 11:35
Common Failure Modes - How to Avoid Band-Aid Solutions
- Discuss the recurring patterns that plague organisations regardless of size, therapeutic area or technology platform
- Look at sustainable solutions that prevent problems from recurring, not just cleaning the current mess
- Suzie Henderson - Director, Regulatory Operations, Regulatory Affairs, Shionogi Europe
- Alessandra Sech - Global Head of Regulatory Operations, Merz Therapeutics
11:35 - 12:15
Doing More with Less and Digital Transformation - Closing the Adoption Gap
- Identify the specific hurdles faced in adopting digital solutions, including transparency requirements, and explore strategies to close the adoption gap
- Frameworks for continuous improvement in pharmaceutical operations
- Practical approaches to doing more with less in digital initiatives
- Patrick Middag - Principal Regulatory Affairs Lead, HRIM Program, Servier
- Sabeeh Habib-Ullah - Associate Manager Regulatory Information Management, Regeneron
Showing 1 of 1 Streams
Networking Break
12:15 - 13:15
Networking Luncheon
Showing 1 of 1 Streams
General Session
13:15 - 14:00
The New Era of Regulatory Collaboration - Building Successful Partnerships Across Health Authorities and Industry
- Understand the drivers behind increased collaboration among health authorities and between industry and regulators
- Explore real-world examples including FDA-EMA joint initiatives and the PRISM project
- Identify opportunities for your organiation to participate in or initiate collaborative efforts
- Christian Hay - Chair, ISO - International Organization for Standardization
- Zainab Aziz - Associate Director RA Policy and Strategic Operations- SSA, Novartis
- Stefano Accorsi - Global Regulatory Affairs Policy and Intelligence Lead, Chiesi Farmaceutici
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim
14:00 - 14:30
Reflections & Roadmaps – A Speaker-Led Open Forum on IDMP, e-Submissions and Beyond
- Understand practical challenges and lessons from early adopters of eCTD 4.0 and modular submission strategies to accelerate implementation
- Recognize that AI value depends on foundational data and governance work; focus first on data quality, standards and interoperability
- Take forward insights on cross‑authority collaboration, NPL implementation implications and where multi‑stakeholder initiatives create opportunities
- Quentin Darrasse - Data Strategy Principal, Roche
- Frits Stulp - Chairman of the Board, CTADHL
- Karim Kacimi - Global Regulatory Policy & Advocacy Senior Specialist, Novo Nordisk
14:30 - 14:35
End of Conference
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