In our last session on XaaS and AI, we presented an approach for implementing cloud and AI technologies in regulated environments. The natural next question is: where does an organization begin? For regulatory affairs professionals, the answer comes back to one thing: how well your regulatory information is structured and managed. In this session, we will explore a system built with this exact objective in mind: the Regulatory Information Management (RIM) system.
Regulatory Affairs teams are under growing pressure: more markets, more submissions, more data, faster timelines. Yet, many still rely on spreadsheets, shared folders, and disconnected systems to manage it all. It functions, until a market expansion, a regulatory inspection, or a product lifecycle event exposes just how fragile that infrastructure is. Regulatory Information Management (RIM) exists to solve this issue. It centralizes and structures regulatory information: submissions, registrations, product information, dossiers, and compliance history, making it searchable, traceable and audit ready. This webinar offers a practical introduction to RIM: what it is, what it covers, how it differs from other systems, and why organizations that build a solid RIM foundation gain a structural advantage in speed, accuracy, and regulatory resilience. We’ll walk through how RIM functions as the connective layer of a modern regulatory operations ecosystem. We will also walk through what a realistic path to adoption looks like, whether starting from scratch or migrating from existing tools, so attendees leave with a clear sense of where to begin.
Learning Objectives
By the end of this one-hour webinar, participants will:
- Understand what Regulatory Information Management (RIM) is, how it differs from adjacent systems and what operational problems it solves
- Recognize the operational and compliance risks of fragmented regulatory data and why those risks grow as organizations scale or pursue digital transformation
- Understand how a RIM system connects the regulatory data ecosystem through shared master data, and what that means for submissions, registrations, quality, and safety workflows
- Identify the key considerations for assessing readiness and approaching RIM adoption, including what a realistic path from initial implementation to a fully connected regulatory operations environment looks like
Who Should Attend
- Regulatory Affairs professionals managing submissions, registrations, or product dossiers
- QA/Compliance leads overseeing data integrity and audit readiness
- IT and digital transformation leaders in regulated life sciences environments
- Validation and CSV specialists evaluating new platform categories
- Organizations considering or currently planning a RIM implementation
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
