Day 3 - October 23rd
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Christian Hay - Sr Advisor Healthcare, GS1 Global Office
Business case and current experiences of enhancing and implementing a new regulatory information management system
sImplementation strategy, roadmap, challenges, opportunities
- Process framework, Data landscape, Change Management
- Is AI playing a role?
Which areas are currently lagging behind?
- Patrick Middag - Principal Regulatory Affairs Lead, Servier
- Enhancing data quality through innovative ontologies
- Streamlining product management with integrated tools
- Driving efficiency across product lifecycle management
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
- Heiner Oberkampf - CEO and Co-Founder, Accurids
- Maren von Fritschen - Head Regulatory Policy EU, University of Applied Sciences
- What does the new legislation say in relation to labelling?
Opportunities with wider adoption
- Chiara Bernini - Senior Manager Public Policy Healthcar, GS1
- Sophie Molle - Senior Manager Healthcare Community Engagement, GS1
Explore how eCTD 4.0 accelerates the shift from document-centric to data-driven submissions, and why unified RIM is essential to drive faster submissions.
Understand how data unification helps manage 4.0’s complexity and ensure compliance
Learn how structured data, controlled vocabularies, and context of use enable accuracy and efficiency
See how a centralized, data-driven approach helps avoid rejections and drives process efficiency
- Vicki Cookson - Senior Director, Regulatory Strategy EU, Veeva
How are companies already employing electronic product information?
Successes, pitfalls, and solutions to overcome
How can ePI revolutionise the future of patient care
- Abdul Mateen - Director, Healthcare Consultancy Services
- Katja Pecjak Reven, M.Sc. Pharm. - Owner, Subject Matter Expert for ePI, Head of Regulatory Affairs, Billev Pharma East
- Peter Koop - CEO, Cormeo
With so many systems and platforms in place, how are companies dealing with data ownership?
Does ownership also differ by region?
Processes for ensuring data quality and resolving data issues with multiple input sources
Enhanced collaboration for more accurate and usable data
- Ana Montoya Alarcon - Director Regulatory Systems Lead, Daiichi Sankyo
- Alessandra Sech - Head of Global Regulatory Operations, Merz Therapeutics
Developing generic IDMP capabilities independently from the RIM system has gained increasing interest, similar to how eCTD publishing is handled separately from eDMS.
The expected benefits of this approach include the ability to adapt more quickly and efficiently to evolving regulatory guidance and requirements, without disrupting ongoing regulatory affairs (RA) activities, either in terms of systems or resources.
This presentation will explore the main challenges of this strategy, in particular:
- How to optimize RIM–IDMP integration through automation,
- How to minimize IDMP enrichment that is not reflected in source systems (such as RIM),
- How to manage inconsistencies across RIM systems, IDMP systems, and PMS.
- Pierre Stanislawski - Regulatory Product Director, Ennov
- Maxime Delpire - Regulatory Information Management Expert, Ennov
Provide an update on the activities of the ROG, highlighting advancements in digital transformation, process optimisation, and collaboration between Industry and Regulators.
- Establishing PMS as a shared, validated and trusted source for the EU Network
- Enhancing data integrity and interoperability
- Proof of concept of variation optimisation
- Remco Munnik - Vice President, IRISS Forum