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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, trade, and pricing
- 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
09:45 - 10:45
[KEYNOTE PANEL] Implementation of General Pharmaceutical Legislation (GPL) - The Reality of the EU’s New Regulatory Environment
- Navigate new dynamics and what they mean in practice by gaining pragmatic approaches for effective implementation and application strategies
- Examine key areas the industry should focus on in the next two years, such as milestones for successful compliance with GPL
- Bridge the gap between regulatory theory and operational reality and discuss implications for regulatory data
- Rebecca Lumsden - Head of Regulatory Science and Policy, Sanofi
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 - Vice President, IRISS Forum
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 - Global Quality Manager, Roche
- Laurent Desqueper - Digital Technology Lead Intelligent Content Generation, UCB
Showing 1 of 1 Streams
Networking Break
12:45 - 13:45
Networking Luncheon
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 - 14:35
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, Veeva RIM Strategy, Enterprise, Veeva
- Alessandra Sech - Global Head of Regulatory Operations, Merz Therapeutics
- Ana Montoya Alarcon - Regulatory Systems Lead Director, Daiichi Sankyo
13:45 - 13:55
Track Chair's Opening Remarks
- Christina Juli - Head of CMC Management CMB, Boehringer Ingelheim
13:55 - 14:35
Implications of the Biotech Act on Clinical Trials
- 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
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 - Global Quality Manager, Roche
16:30 - 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
- Ese Aziza - Data Strategy & Management Platform Lead, Novartis
15:45 - 16:30
MHRA’s New Data Strategy Decoded
- Hear practical insight on MHRA’s data-driven future, explore real-world applications for industry and gain clarity on digital engagement platforms
- Answer guiding questions like - What does this new legislation mean for our regulatory strategy?
- Catherine Russell - Data Architect, Digital Technology Group, Medicines and Healthcare Products Regulatory Agency
16:30 - 17:15
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 - Global CMC Senior Manager, Pfizer
Showing 1 of 1 Streams
Networking Break
17:15 - 18:15
End of Day 1 and Networking Reception
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