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
Current experiences of enhancing and implementing regulatory information management systems
Is AI playing a role?
Which areas are currently lagging behind?
Are companies outsourcing their RIM systems or curating them in-house?
Future planning of further RIM reform
Future-proofing systems and teams
- 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
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
What does the new legislation say in relation to labelling?
Opportunities with wider adoption
Native scanning of GS1 Data-Matrix pilot project
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
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
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
Take the time to reflect on the last 3 days of learning from GPRAS and have any last-minute burning questions answered by our panel of experts!