FutureRegulatorySummit2026
The two-day free virtual summit for regulatory leaders
We can’t wait either
The submission playbook is being rewritten.
Regulatory submissions are entering their biggest shift in a generation. In two focused days, we'll cut through the noise on the questions leaders are actually facing — whether your data is an asset or a liability, if your RIM can keep pace with your ambitions, what reliance really means in the cloud era, and where AI genuinely earns its place in RegOps.
Day 1: Five sessions. Zero filler.
Embracing a New Era: First Look at the Fall 2026 RIM Benchmark — Opening Keynote
A convergence of change has ushered in a new era for life sciences, with significant impact and opportunity for regulatory professionals. The harder question is what it actually takes to benefit from it.
Steve Gens opens the summit with the first public look at the October 2026 Regulatory Intelligence and Organizational Implications of AI survey coupled with the recent Operational Excellence and World Class RIM benchmark. Drawing on more than a decade of tracking the same measures across the industry, he will set out what has changed, what has not, and what this year's data suggests about where regulatory organisations are heading.
The session covers fourth-generation information architecture and what it means in practice, the new ways of working and cross-functional structures the transition demands, and the latest evidence on the organizational impact of AI. Running underneath is a consistent finding from the benchmark: technology alone does not separate the organizations that perform from those that do not.
RIM in the New Era: Are Your Systems Keeping Up With Your Ambitions?
Most organizations have a RIM system. Far fewer have a RIM capability. The platform goes live, the program team disbands, and eighteen months later the spreadsheets are quietly back in circulation while the roadmap that justified the investment is still sitting on slide 14. Meanwhile, eCTD 4.0 moves from pilot to reality.
This panel is about the distance between technical go-live and business go-live, with RIM system owners and 4.0 practitioners who have run modernization programs end to end, including the parts that didn't go to plan.
Tech Spotlight: Kivo.io
Keeping AI GxP Compliant with Kivo: Achieve Efficiencies Without Compliance Risk
Can you use AI for RegOps and still be GxP compliant? Yes, if you're using Kivo's Headless GxP. AI brings a host of generative and agentic possibilities - from everyday efficiencies to whole new ways of authoring & reviewing submission documents. But RegOps teams are typically forced to either limit their use of AI, or accept the compliance risk of AI agents taking unvalidated actions. Come see how Kivo's Headless GxP solution enables AI advantages within a validated, GxP-compliant framework.
Kivo is the compliance platform for clinical-stage biotech teams and the partners that support them, from pre-IND through approval. Kivo offers a shared workspace where every function - Regulatory, Clinical & Quality - can manage their documents, activities, and even vendors in a way that's intuitive, efficient, and compliant. Their unified, CSA-validated platform means fast setup and easy management, without the enterprise overhead.
From Data Chaos to Data Capital: Why Regulatory Data Quality Is Now a Strategic Issue
Regulatory data has been treated as a byproduct of submissions for decades: created to fill a field, satisfy a requirement, and get a dossier out the door. PQ-CMC, ePI and AI all now ask the same question of it – is this structured, governed and trusted enough to reuse? And for most organizations the honest answer is still no.
This panel looks at what changes when data quality stops being a cleanup exercise and starts being treated as capital, with named owners, agreed standards and a measurable return.
Tech Spotlight: DAQUMA
The Most Expensive Wait in AI: "Get Your Data Ready First”
Life sciences has spent years waiting for perfect data before starting with AI. But AI doesn't have to wait for the foundation. Used well, it can help build it. Building on the discussion of regulatory data quality, this session shows how leading organizations are using AI to expose, remediate and govern data quality rather than waiting for it to be fixed. Through real-world GxP examples, DAQUMA will explore why trust, auditability and human accountability make this work, and whether your organization is ready to trust AI to help get there.
DAQUMA connects Clinical, Quality, Regulatory, and Safety systems, putting AI agents to work, analyzing data, assisting your teams, and delivering actionable insight in seconds. From document intake to review and quality checks, it turns manual processes into fast, compliant workflows, built on a governed platform with compliance at its core.
Day 2: Five sessions. Zero filler.
Day 1 Recap
Day 1 covers a lot of ground: the first public look at the Fall 2026 RIM benchmark, a candid panel on the distance between RIM go-live and RIM capability, and a hard look at whether regulatory data is an asset or a liability. We open Day 2 by pulling the threads together.
Fifteen minutes on what was actually said, where the panelists disagreed, and which points are worth carrying into the sessions ahead on AI, collaboration and reliance. If you missed day one, this will get you oriented. If you were there, it is a chance to see how the arguments connect before the conversation moves on.
AI in RegOps: Separating Signal from Noise
There's no shortage of AI claims aimed at regulatory teams, and very little agreement on which survive contact with a regulated process. Teams are being asked to evaluate tools faster than they can build the validation, governance and data foundations those tools depend on, and the gap between what gets demonstrated and what gets deployed keeps widening.
This panel is deliberately skeptical: practitioners running live AI and automation work on where it's genuinely adding value today, what had to be true before it worked, and how they validate and govern GenAI for regulatory use.
Tech Spotlight: Weave.bio
From Documents to Knowledge: How Weave Customers Win with AI
Drug development runs on documents — but documents were never the point. They're imperfect containers for the knowledge inside them, and managing them consumes time, money, and focus that should go toward getting medicines to patients faster. This session moves past the AI hype cycle to show what's actually working: real Weave customers who've gone beyond superficial automation to work directly with their knowledge and data. We'll share concrete stories of teams who've transformed how they author, verify, and communicate regulatory content — and the results they're seeing.
Weave is re-shaping drug development with AI, evolving the way therapeutic knowledge is maintained, applied, and communicated. Weave's AI-native platform supports the entire regulatory knowledge lifecycle, from initial planning and content reuse through authoring, review, submission, and post-submission response.
The Collaboration Imperative: Reliance, Cloud, and the End of the One-Way Submission
Reliance pathways, Project Orbis, ACCESS and cloud-based regulatory spaces all point the same way: submission as a shared, structured exchange rather than a package thrown over a wall. The models exist and the pilots have run. What hasn't caught up is the operating reality inside most sponsors, where data, systems and internal governance were all built for one-way handoff.
This panel gets past the conference-slide version into what actually changes for a sponsor, what the sequencing looks like, and where the honest limits sit today.
Tech Spotlight: cormeo
The Future of Regulatory Collaboration
In this spotlight, we will talk about "The Future of Regulatory Collaboration", including Cloud-Based Regulatory Spaces (CBRS) which are emerging as a critical component of modern regulatory ecosystems. Regulatory authorities and Marketing Authorization Holders (MAHs) face unprecedented challenges in managing the complexity and volume of regulatory data. Traditional systems, often document-centric and siloed, struggle to accommodate the requirements of modern pharmaceutical regulations especially related to collaboration. cormeo has supported the transformation of these processes for decades, providing technology solutions for both industry and authorities, that streamline regulatory operations while ensuring compliance and data integrity.
cormeo is one of the leading providers in the fields of Smart Information Lifecycles building the trusted bridge between industry, authorities, healthcare professionals, and patients. By uniting the expertise of Docuvera, EXTEDO, medicines.ie and Rote Liste, cormeo delivers a seamless, end-to-end approach - a Smart Information Lifecycle - that empowers life sciences companies, authorities, and healthcare professionals to efficiently navigate the complex landscape of medical and regulatory information.
A lineup you won't find anywhere else
Future Regulatory Summit is gathering the industry's leading regulatory experts from across the globe around one virtual table. Our lineup is a "who's who" of the people shaping the future of regulatory submissions at some of the world's biggest and most innovative life science companies. You won't find this anywhere else.
Register for freeThe people shaping what's next
Why we're hosting this event
Putting on an event of this scale is no small feat, but we believe it's a necessary one. Right now, regulatory submissions are at the precipice of a new era—AI, CBRS, eCTD 4.0, IDMP, and many other forces are converging to form an entirely new landscape. All of these topics are being discussed, but rarely in the same room, and almost never with the goal of understanding how they will come together holistically to reshape the future. We wanted to give the community a space to come together, to learn, to ask questions, and to prepare for what's to come.
Who you'll see at Future Regulatory Summit
Don't miss this one
If there's one regulatory event you attend before the end of the year, it should be this one. Leading industry experts, talking about the subjects that truly matter, with an audience of your peers. Save your spot today.