Welcome to RIMScast. Your host is Justin Smulison, Business Content Manager at RIMS, the Risk and Insurance Management Society.

In this episode, Justin interviews Caroline Shleifer, Founder and CEO of RegASK about the RegASK report, “The 2025 State of Regulatory Affairs and Compliance Report.” Justin and Caroline discuss how regulatory affairs professionals see AI adding the most value in three key areas of their day-to-day activity: augmentation, automation, and acceleration. Caroline shares some examples of these areas of AI. The report highlights AI and ESG as areas of increasing regulation. Caroline shares how risk management professionals can best prepare for the unique challenges these emerging regulatory areas present.

The report suggests that AI solutions could transform regulatory affairs work, particularly in summarizing and adapting requirements to specific organizational contexts. Caroline offers her thoughts on risk management roles evolving alongside this AI adoption in regulatory affairs.

Listen for ideas on leveraging AI tech to stay current with the evolving regulatory landscape.

Key Takeaways:

[:01] About RIMS.

[:14] Member registration for RISKWORLD 2025 is now open! General registration opens on December 4th. Visit RIMS.org/RISKWORLD.

[:25] About this episode, coming to you from RIMS headquarters in New York. Our topic is AE adoption and regulatory risks with the Founder of RegASK, Caroline Shleifer.

[:49] The next RIMS-CRMP Exam Prep Virtual Workshop will be held on December 17th and 18th.

[1:00] On February 19th and 20th, there is a two-day virtual workshop for the RIMS-CRMP led by former RIMS President Chris Mandel and presented by the RIMS Greater Bluegrass Chapter, the 2024 RIMS Chapter of the Year.

[1:18] The next RIMS-CRMP-FED Exam Course will be held from February 4th through the 6th, 2025. Links to these courses can be found on the Certification page of RIMS.org and through this episode’s show notes.

[1:34] RIMS Virtual Workshops! Elise Farnham of Illumine Consulting recently joined us here on RIMScast. On December 17th and 18th, she will host “Captives as an Alternate Risk Financing Technique”.

[1:49] Gail Kiyomura of The ART of Risk Consulting, will host the “Fundamentals of Insurance” virtual workshop on February 19th and 20th, 2025.

[2:00] This is the last week to sign up for “Managing Data for ERM”, hosted by Pat Saporito on December 12th. Registration closes on December 11th.

[2:12] A link to the full schedule of virtual workshops can be found through RIMS.org/education/online-learning pages. A link is also in this episode’s show notes.

[2:26] Interview! The adoption of Artificial Intelligence in an enterprise’s operations, workflows, and processes is on our members’ minds. AI presents its own unique set of regulatory risks. My guest today is here to discuss insights about AI adoption.

[2:46] She is Caroline Shleifer, the CEO and Founder of RegASK, which recently released “The 2025 State of Regulatory Affairs and Compliance Report.” She is here to discuss some of the trends that she noticed from the surveys of senior executives and business leaders.

[3:04] She shares her perspective on the upside potential of AI adoption and ways that risk professionals can work alongside regulatory professionals to ensure everything runs smoothly and above board. We’ve got data, trends, and perspectives to explore.

[3:21] Caroline Shleifer, Welcome to RIMScast!

[3:49] RegASK’s new report is “The 2025 State of Regulatory Affairs and Compliance Report.”

[4:15] Caroline worked for years in the life science and consumer product industry, helping them scout innovation in ingredients and technology and helping them put it on the market.

[4:47] Doing that, Caroline realized that many times there was a challenge in understanding which regulations applied or in being caught off guard by a regulation they were not aware of. Sometimes these regulations prevent businesses from launching a product as they plan.

[5:28] It’s important to understand and catch up with the fast-moving regulatory environment. The challenge is understanding what applies to an organization well in advance so there are no delays or non-compliance. This is a recurring challenge for small and large companies.

[6:00] Caroline looked at the technology used in the banking and finance systems to help with compliance. She wondered why not apply that technology to the consumer product and life science industry to develop a product to help the regulatory affairs team stay current.

[6:35] About six years ago, Caroline founded RegASK, starting small with her clients in the consumer products and consumer health industry. She expanded it progressively to larger geographies and industry verticals.

[7:06] Caroline respects risk professionals as they deal with challenges that are often overlooked by other business units. When the work is well done, no one sees it, as it seems seamless. No one sees the day-to-day work behind the scenes to prevent non-compliance.

[8:02] Risk professional teams are usually understaffed. The risk of non-compliance can range from stopping a product from being imported to stopping a clinical trial or having a big financial impact.

[8:45] Sometimes the compliance manager is the default risk manager and wears many hats.

[9:33] When Caroline formed RegASK, she saw something like AI was coming. She didn’t see how quickly it would come. Things that took RegASK years to develop a few years ago, take less than a year to develop now. RegASK has accelerated its roadmap due to recent developments.

[10:49] According to the RegASK report, 38% of regulatory affairs professionals feel at risk of non-compliance due to unawareness of specific regulations. That agrees with the feedback RegASK gets from its clients.

[11:21] It’s very challenging to understand every regulation. RegASK provides the curation of regulatory information and helps pass the information to the right teams at the right moment with the right language, including what the impact and risk may be for different business units.

[12:27] The report says 27% of senior executives expect regulatory risks to have the biggest impact on businesses in 2025. Everyone should be aware of these risks and be attentive to understanding the landscape and what is happening around them.

[13:17] Monitor regulatory agencies. Learn where and how to collect information and who should get the information you collect. Get training for the regulatory affairs team and the broader company on how to collect, summarize, and convey this information.

[14:04] The third point is to understand that now you have some technology that can help in this process. Understand what your needs are and adopt AI technology to some aspects of your workflow to solve some critical challenges you have.

[14:34] Understand what your workflow is. If you digitalize a process that is not optimal, you end up with a suboptimal digitalization and outcome. Study your current process and challenge it to see how it could be improved. Understand where technology can be leveraged in your process.

[15:10] RegASK helps companies to understand their workflow and how it can be improved. Caroline recommends picking the right partner to help you. Caroline notes that RegASK has been featured in a Gardner industry report on regulatory agencies and technology solutions.

[16:18] Plug Time! RIMS Webinars! On Thursday, December 12th, our final RIMS Webinar of 2024 will be presented by OneTrust: “Staying Vigilant: 7 Practical Tips for Ongoing Third-Party Risk Monitoring”.

[16:35] More webinars will be announced soon and added to the RIMS.org/webinars page. Go there to register. Registration is complimentary for RIMS members.

[16:47] RIMS is now accepting nominations for all awards other than Risk Manager of the Year 2025. The submission deadline is Monday, January 6th, 2025. To receive a RIMS award, all winners must be active members and in good standing.

[17:07] These awards are the Diversity, Equity, and Inclusion Chapter Leadership Award, the Harry and Dorothy Goodell Award, the Volunteer of the Year “Heart of RIMS” Award, the Richard W. Bland Memorial Award, the Chapter of the Year Award, the Rising Ris...

AI and Regulatory Risk Trends with Caroline Shleifer