Epista Life Science

The free two-day virtual summit for regulatory leaders on the future of regulatory submissions. November 18-19, 10am to 12pm ET.

A deliberately critical panel on AI in RegOps, with practitioners from Takeda, Amgen, and Weave Bio on what actually survives a regulated process.

I want to be upfront about this agenda: We built it around an argument. The industry keeps talking about RIM as a technology decision. Which platform, which version, which implementation partner. Meanwhile the benchmark data has been saying the same thing for over a decade: performance doesn't track to the platform. Organizations running the same software land in completely different places. So the interesting question was never "which RIM to implement". Instead, it's why two companies with identical tooling get opposite outcomes, and what the ones who get it right actually did differently. That question shaped the whole programme. The RIM panel is about the distance between technical go-live and business go-live, with people who have run these programmes end to end, including the parts that did not go to plan. The data quality panel asks whether regulatory data is an asset or a liability. The AI panel is deliberately skeptical. Nobody is coming to tell you their transformation went perfectly. That was the brief. Register for free here: https://lnkd.in/eYtr85zN Free, virtual, 18 and 19 November, 10am to 12pm ET. Hosted by Epista Life Science

Weve been hearing it for a while now: The regulatory submission of the future wont be a document, it will be data. Yet almost nothing about how we work has caught up. Sponsors already hold structured clinical data, structured quality data, structured product data. Health authorities already want to review it as data. And in between, we still lock it inside PDFs so the other side can extract it back out again. Both ends of the conversation are modern. Only the exchange is stuck in 2004. Thats the shift running underneath everything regulatory teams are being asked about right now: eCTD 4.0, IDMP, PQ-CMC, cloud-based review, AI. They get discussed as separate initiatives with separate timelines, but theyre really just one change arriving in pieces. Which is why we built the Future Regulatory Summit around the connections rather than the topics. Two mornings, 18 and 19 November. Steve Gens MSOD opens with the first public look at this years RIM benchmark, and the panels were briefed to cover what didnt work as much as what did. Free, virtual, 10am to 12pm ET. You can register here: https://lnkd.in/eJPAwM3P

Future Regulatory Summit will open with the first public look at the 2026 RIM benchmark data. Registration is open until the sessions begin.

2 days mornings, no cost. 9 sessions on what's next for regulatory submissions, delivered by 24 leading regulatory experts.