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28-30 September 2026
Radisson Brussels Grand PlaceBrusselskeyboard_arrow_right
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Agenda for Day One - Monday 28 September, 2026 - CET
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Agenda for Day One - Monday 28 September, 2026 - CET
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Showing 1 of 1 Streams
Networking Break
07:30 - 08:30
Conference Registration, Networking and Refreshments
Showing 1 of 1 Streams
General Session
08:30 - 08:45
Informa Welcome and Chair's Opening Remarks
- Holly Willhide - Conference Producer, Informa Connect
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim
08:45 - 09:45
[KEYNOTE PANEL] Navigating Health Sovereignty – Strategic Approaches in a Transformed Pharmaceutical Landscape
- Hear why geopolitics matters now more than ever for regulatory affairs
- Explore how evolving US, EU and Chinese policies are transforming pharmaceutical manufacturing and trade
- Discuss how can pharmaceutical companies innovate to ensure resilience and equitable access amidst geopolitical shifts
- Understand regulatory divergence and its implications for multi-market drug development and approval
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim
- Kwee-Lan Tan - Global Regulatory Affairs, Boehringer Ingelheim
- Antoine Jourdan - Public Affairs Director, Servier
- Matthias Heck - Senior Advisor Strategic Alliance Development, EUCOPE
09:45 - 10:45
[KEYNOTE PANEL] Implementation of the New Pharmaceutical Legislation (NPL) - Navigating the New Landscape for Regulatory Operations and e-Submission Teams
- Navigate new regulatory dynamics and their practical implications with a pragmatic roadmap for implementing NPL, EHDS, the EU AI Act, IDMP/SPOR and MDR/IVDR readiness
- Examine key areas the industry should focus on in the next two years, such as milestones for successful compliance with NPL
- Bridge the gap between regulatory theory and operational reality by discussing implications for regulatory data and submissions operations
- Connect with experts and real-world scenarios that translate regulatory change into clear, cross-functional tasks
- Maren von Fritschen - Professor, University of Applied Sciences, Berlin
- Rebecca Lumsden - Head of Regulatory Science and Policy, Sanofi
- Florian Schmidt - Deputy Head of Unit, European Commission
Showing 1 of 1 Streams
Networking Break
10:45 - 11:15
Networking Break
Showing 1 of 1 Streams
General Session
11:15 - 12:00
Practical Perspectives on Leveraging Product Management Services (PMS)
- Gain insight from practical PMS use cases and applications following the EMA’s PMS Information Day and avoid common pitfalls in implementation
- Identify opportunities where product management services add the most value
- Analyse processes, criteria and validation approaches for PMS
- Understand what “quality” means for structured data submissions
- Pierre Stanislawski - Product Director for Regulatory Solutions, Ennov
- Remco Munnik - Owner of Arcana and Board Member, IRISS Forum
- Marcos Fernandez Gomez - Master Data Manager - PMS Product Owner, European Medicines Agency (EMA)
12:00 - 12:45
2030 Vision - The Plan for What’s Ahead
- Striking the balance between where we are now and where we are aiming to end up in the next 10 years
- Define the regulatory organisation of the future and outline what skill sets will be needed
- Explore International Council for Harmonisation (ICH) initiatives beyond eCTD 4.0
- Quentin Darrasse - Data Strategy Principal, Roche
- Laurent Desqueper - Digital Technology Lead Intelligent Content Generation, UCB
- Jesper Kjær - Global Director for Public, Private Partnerships, StratOps, Global Medical Affairs, Novo Nordisk
Showing 2 of 2 Streams
Networking Break
Solution Summit
12:45 - 13:45
Networking Luncheon
13:00 - 13:30
Solution Summit - Presented by Perigord
Change volumes are rising and supply chains are fragmenting. Life sciences organisations are under growing pressure to keep artwork, labelling and regulatory content connected, with ePI mandates adding to the load.
This is the AI paradox in governance: automation promises speed, but faster decisions demand tighter control, not less. Without an auditable, governed framework, acceleration becomes risk rather than relief.
This session, led by Suzanne Ivory (COO, Perigord Data; 25 years in Quality Management and over a decade in Operations), gives a practical framework for assessing automation readiness, connecting Regulatory Information Management and Artwork Management systems, and building a compliant business case for change.
Drawing on deployment evidence from over 200 life sciences clients and 70+ AMS systems, the session walks through real use cases: a regulatory change impact analysis that unifies RIM and AMS data, and an artwork automation case that cuts manual formatting from over three hours to under three minutes.
Attendees leave with concrete criteria for evaluating automation partners and platforms, and time to compare notes with peers facing the same regulatory and operational pressures.
- Suzanne Ivory - COO, Global Software Division, Perigord Premedia
Showing 2 of 2 Streams
Regulatory Information Management
Regulatory Updates and Legislative Landscapes
13:45 - 13:55
Track Chair’s Opening Remarks
- Patrick Middag - Principal Regulatory Affairs Lead, HRIM Program, Servier
13:55 - 14:30
RIM Platforms - Optimising Technology for Regulatory Excellence
- Understand the backbone of modern regulatory operations, including how to manage complex global submissions, maintain compliance and drive operational efficiency
- Evaluate key features and capabilities essential for modern RIM systems
- Identify best practices for successful RIM implementation and change management
- Hear how to optimise integration between RIM platforms and other enterprise systems
- Vicki Cookson - Senior Director, Regulatory Strategy, Veeva
- Ana Montoya Alarcon - Head of Global Regulatory Systems Operations, Daiichi Sankyo
14:30 - 15:15
The Adoption Realities of eCTD 4.0
- Gain a better understanding of what has happened so far with eCTD4.0 adoption
- Identify key lessons from early adopters and implementation challenges
- Hear what steps need to be taken to move toward data driven decision making
- Assess impacts of implementation on the small-scale industry
- Maren Müller - Senior Product Manager, EXTEDO
- Priya Krishnan - Business Consultant, EXTEDO, a cormeo brand
13:45 - 13:55
Track Chair's Opening Remarks
- Christina Juli - Head of CMC RA Office NBE, Boehringer Ingelheim
13:55 - 14:30
Implications of the Biotech Act
- Hear practical considerations and anticipate the impact - how will this new legislation framework support early innovation?
- Approaches to simplify clinical trial rules - changes to CTR, GMO legislation and ATMP rules, while addressing challenges in genetic modification and trial phases
- Explore how the Biotech creates risk-proportionate pathways and early-stage support and learn how to leverage these mechanisms to accelerate development and market entry
- Assess practical implications for dossier content, CMC and environmental risk assessments and identify immediate changes to R&D, manufacturing and regulatory strategies to remain compliant and competitive
- Marta Provencio - Regulatory Affairs Manager, EUCOPE
14:30 - 15:15
US Food & Drug Administration (FDA) Forum
- Glean policy updates from the FDA
- Learn how to qualify for, obtain and maximize value from approval vouchers
- Understand the modernisation of the FDA’s electronic submissions and IDMP workstream
Showing 1 of 1 Streams
Networking Break
15:15 - 15:45
Networking Break
Showing 2 of 2 Streams
Regulatory Information Management
Regulatory Updates and Legislative Landscapes
15:45 - 16:30
Owning RIM - Data Literacy Empowerment
- Gain practical strategies to build data literacy within your organisation with job-relevant approaches
- Hear the use cases that demonstrate the direct connection between data quality and regulatory success and how to enforce and empower these strategies
- Quentin Darrasse - Data Strategy Principal, Roche
- Sheila Elz - Senior Regulatory Information Manager, Boehringer Ingelheim
- Jack Daley - Director, Regulatory Data Governance Lead, Gilead
15:45 - 16:30
Regulatory Agility Redefined - Europe’s Transformed Variations Framework
- Examine the implications on Marketing Authorisation Holders (MA) and how they manage, submit and process changes to their authorised products
- Translate what is changing in practice for the handling of post-authorisation variation across the EU
- Alessandra Leone - Director, Regulatory CMC & Lifecycle Strategy, Pfizer
Showing 1 of 1 Streams
General Session
16:35 - 17:15
Unlocking the Potential of ePI and Structured Data in EU Pharmaceutical Legislation
- Explore the impact of the new EU Pharmaceutical legislation on electronic Product Information (ePI) and its role in modernising product communication
- Examine how structured data standards like IDMP enable seamless integration and enhance the accuracy of ePI
- Discuss practical strategies for aligning IDMP data with ePI requirements, addressing implementation challenges and leveraging benefits for regulatory compliance and patient safety
- Anne Linner - EPL, System Owner, PharmaProtect Solutions GmbH
Showing 1 of 1 Streams
Networking Break
17:15 - 18:15
End of Day 1 and Networking Reception
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