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
PLM Portal status
Which implementation stage has been reached and what are the next steps?
SPOR implications on eAF functionality
Timelines for industry to be aware of
Link to PMS data
- 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
Current industry use cases of using SCA
Which parts of submissions has SCA enhanced?
Relationship with IDMP
Use of AI in SCA
Which steps are vital when embarking on your own SCA journey?
- Manda Pasarkar - Global Regulatory Team Lead, Sanofi
- 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
What does the new legislation say in relation to labelling?
Opportunities with wider adoption
Native scanning of GS1 Data-Matrix pilot project
- Chiara Bernini - Senior Manager Public Policy Healthcar, GS1
- Sophie Molle - Senior Manager Healthcare Community Engagement, GS1
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 - Regulatory Operations Manager, Tiefenbacher Group
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 - Product Director, Ennov Regulatory
Please contact: Lisa Marzoli – lisa.marzoli@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
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
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
As pharma continues to develop ways to collect, store, and leverage their data, what can we learn from other industries?
How are alternative industries ensuring their data is readable, useable, and secure?
Which challenges did they experience in refining their platforms and processes? And how were they overcome?
Which lessons can pharma companies apply to their own data and submission processes?
Opportunities and challenges under new EU data laws and ability to use such data in regulatory submissions