Day 3 - October 23rd
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