Agenda - Agenda for Day Three - Wednesday 30 September, 2026 | Global Pharmaceutical Regulatory Affairs Summit

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Networking Break

08:30 - 09:00

Networking Breakfast

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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 Data Domain Owner Product and Substance, Boehringer Ingelheim

09:40 - 10:15

IDMP Implementation Realities - What the Pioneers Learned (So You Don’t Have To)

Learn practical strategies to leverage IDMP standardization to streamline global implementation and reduce regulatory friction
Gain clear insights into the measurable benefits IDMP delivers for industry and regulators, such as improved data quality, faster submissions and fewer information requests
Discover actionable next steps and prioritisation guidance to align your data, teams and processes with IDMP requirements

Marilina Castellano - Product Manager, Uppsala Monitoring Centre (UMC)

09:00 - 09:10

Track Chair’s Review of Day Two

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

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Networking Break

10:15 - 10:45

Networking Break

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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

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Networking Break

12:15 - 13:15

Networking Luncheon

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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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Agenda for Day Three - Wednesday 30 September, 2026Wednesday, 30 September 2026 - CET

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