Share
))
HBO and The Ringer's Bill Simmons hosts the most downloaded sports podcast of all time, with a rotating crew of celebrities, athletes, and media staples, as well as mainstays like Cousin Sal, Joe House, and a slew of other friends and family members who always happen to be suspiciously available.
…
continue reading
Manage episode 521321153 series 3610753
Content provided by Don Davis PhD, MBA. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Don Davis PhD, MBA or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.
Moderator: Ian Crone, ArisGlobal
Panellists:
- Remco Munnik (Arcana Life Sciences)
- Peter Brandstetter (Accenture)
- Frits Stulp (Implement Consulting Group)
In this episode, the focus is on IDMP and its role in transitioning from document-based to data-driven regulatory affairs. Key points include the status of IDMP adoption within the EU, the readiness and challenges of current systems, and the potential of structured data to empower AI applications.
The conversation highlights how structured, high-quality product data can enhance regulatory processes, from signal detection to submission automation. Participants stress the importance of robust data foundations, referencing examples from other industries and emphasizing the transformative potential of data governance. The discussion concludes with actionable steps for companies to make meaningful progress, emphasizing the alignment of leadership, structure, tooling, and mindset in embracing data and AI for improved healthcare delivery.
00:42 Episode Overview: IDMP in Motion 01:04 Guest Introductions 01:35 Current State of EU IDMP Adoption 03:01 EMA's Role and Data Management 08:04 AI Applications in Regulatory Affairs 12:22 The Importance of Data Quality 13:07 Future of AI and IDMP in Regulatory Affairs 17:35 Challenges and Solutions for Implementation 23:39 Predictions for the Future 28:45 Actionable Steps for Companies 32:12 Conclusion and Final Thoughts
5 episodes
