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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
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 Products and Substances, 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
- Toni Isaacs - Senior Data Manager, GSK
09:00 - 09:10
Track Chair’s Review of Day Two
09:10 - 09:40
Electronic Product Information (ePI) - Preparing for the Next Digital Regulatory Transformation
- Gain key Health Authority Updates, such as EMA timeline and requirements for ePI implementation in the EU
- Conduct readiness assessment of your organisation’s current state v. ePI requirements
- Compare your current implementation status to eCTD 4.0
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 2 of 2 Streams
Regulatory Information Management
Global eSubmissions
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
- Gain real-world case studies from companies that broke the cycle and found the solutions that saved their data quality - how to implement your own diagnostic criteria
- Suzie Henderson - Senior Submission Manager, Shionogi Europe
11:35 - 12:00
Resource Optimization Strategies 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
10:45 - 11:35
Digital Regulatory Pathways - eSubmissions, ePortals & eLabeling Explore t
- 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
- Kimty Bui-Van - Global Vice President Regulatory Affairs, Septodont
- Jianhui Zheng - Regulatory Affairs Senior Manager, SEPTODONT
11:35 - 12:00
Advancing Regulatory Innovation – Trusted Regulatory Spaces and Cloud-Based Submissions
- Learn how TRS differ from traditional submission processes, their role in securing data sharing and their potential to facilitate early regulatory dialogue and reduce development timelines
- Get a status update on cloud submission capabilities at Health Authorities worldwide and practical insights into what cloud-based submissions mean for industry
- Explore ongoing TRS projects, such as Proof of Concepts (POCs) and discover decision frameworks for adopting cloud submissions to enhance efficiency and regulatory intelligence
- Claudio Schnyder - Associate Director - Submission Management, Novartis Pharma AG
Showing 1 of 1 Streams
Networking Break
12:00 - 13:00
Networking Luncheon
Showing 1 of 1 Streams
General Session
13:00 - 13:45
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
- Zainab Aziz - Associate Director RA Policy and Strategic Operations- SSA, Novartis
- Stefano Accorsi - Global Regulatory Affairs Policy and Intelligence Lead, Chiesi Farmaceutici
- Ana Padua - Associate Director - Global Regulatory Affairs CMC Regulatory Intelligence, Merck Group
14:30 - 14:35
End of Conference
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