2024
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About the Webinar

2026 is set to be a transformative year for regulatory affairs. The shift will not be defined by a single rule change, but by the convergence of four powerful forces: safety, sustainability, sovereignty, and software. 

Join us for a 45-minute session as we unpack what RegASK’s platform data, expert community, and global regulatory bodies are signalling, and what every regulatory affairs (RA) leader must be ready for as we enter 2026. 

Here’s what you can expect: 

  • Signals RA Leaders cannot ignore: The regulatory shifts gaining the most momentum across markets and product categories. 
  • Trend anchors: Deep diving into the key topics within each force that will influence regulatory planning in 2026. 
  • What this means for RA Leaders: The capabilities, processes, and strategic levers needed to stay ahead of accelerating regulatory demands. 

 Discover the forces reshaping regulatory affairs and see how forward-looking teams are preparing for the next chapter of global compliance. 

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About the Speaker

Caroline Shleifer is the Founder and CEO of RegASK, a global RegTech company transforming how organizations manage compliance through AI-driven regulatory intelligence. With a vision to simplify and accelerate regulatory decision-making, she has positioned RegASK at the forefront of innovation in agentic AI and workflow orchestration.

Holding a PharmD-PhD in Medical Physics from the University of Paris V, Caroline brings a strong scientific foundation to her leadership. Before founding RegASK, she led Regulatory & Scientific Affairs (APAC) for an international medical-science consultancy, guiding projects across the United States, Europe, and Asia.

Recognized by Supply & Demand Chain Executive as a 2025 “Pro to Know,” Caroline continues to champion the use of advanced analytics and intelligent automation to help companies navigate complex global regulations with confidence, agility, and precision.

Kelli Madden, RAC-Drugs, Senior Regulatory Intelligence Manager at RegASK, brings over 15 years of experience in regulatory intelligence with expertise in the pharmaceutical and dietary supplement industries. She has built her career helping organizations navigate global regulatory developments, offering timely insights and strategic impact assessments to support compliance and decision-making.

She holds the RAC-Drugs credential from the Regulatory Affairs Professionals Society and is pursuing her M.S. in Regulatory Affairs and Quality Assurance at Temple University, further deepening her knowledge of regulatory frameworks, quality systems, and emerging compliance trends.

Alice holds an Engineering degree in Biotechnology and has over 15 years of regulatory affairs experience in the food industry, specializing in EU, Canadian, and US legislation and Codex Alimentarius standards. Before joining RegASK, she worked as a Regulatory Affairs Manager at European (SNE) and International (ISDI) trade associations, representing the dietetic food industries and later as a Nutritional Marketing Specialist for infant formula at Nestlé. After transitioning into consulting in the US, Alice joined RegASK in January 2021 as an expert and became Regulatory Affairs Project Manager in September 2021, focusing on food supplements, infant formula, and novel ingredients.

2024
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Watch Webinar Replay

About the Webinar

2026 is set to be a transformative year for Regulatory Affairs. This shift will be defined by the convergence of four powerful forces: safety, sustainability, sovereignty, and software, which will reshape how teams operate and make decisions.

Join Caroline Shleifer, Founder & CEO of RegASK, joined by Subject Matter Experts Alice Gravereaux and Kelli M. Madden, as they unpack exclusive insights from the RegASK platform and our global experts’ community to highlight the signals that matter most for 2026.

Here’s what you can expect: 

  • The key signals Regulatory Affairs leaders can no longer ignore
  • The structural shifts driving today’s global regulatory trends
  • What this new wave of change means for teams, planning, and decision-making

Discover the forces reshaping Regulatory Affairs and see how forward-looking teams are preparing for the next chapter of global compliance.

REGASK WEBINAR SERIES

Regulatory Affairs Trends 2026: AI, Safety, Trade, and more

Date: December 11, 2025

Time: 10am EST / 4pm CET

Duration: 45 minutes

Speaker: Caroline Shleifer, Alice Gravereaux and Kelli M. Madden

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About the Speaker

Caroline Shleifer is the Founder and CEO of RegASK, a global RegTech company transforming how organizations manage compliance through AI-driven regulatory intelligence. With a vision to simplify and accelerate regulatory decision-making, she has positioned RegASK at the forefront of innovation in agentic AI and workflow orchestration.

Holding a PharmD-PhD in Medical Physics from the University of Paris V, Caroline brings a strong scientific foundation to her leadership. Before founding RegASK, she led Regulatory & Scientific Affairs (APAC) for an international medical-science consultancy, guiding projects across the United States, Europe, and Asia.

Recognized by Supply & Demand Chain Executive as a 2025 “Pro to Know,” Caroline continues to champion the use of advanced analytics and intelligent automation to help companies navigate complex global regulations with confidence, agility, and precision.

Kelli Madden, RAC-Drugs, Senior Regulatory Intelligence Manager at RegASK, brings over 15 years of experience in regulatory intelligence with expertise in the pharmaceutical and dietary supplement industries. She has built her career helping organizations navigate global regulatory developments, offering timely insights and strategic impact assessments to support compliance and decision-making.

She holds the RAC-Drugs credential from the Regulatory Affairs Professionals Society and is pursuing her M.S. in Regulatory Affairs and Quality Assurance at Temple University, further deepening her knowledge of regulatory frameworks, quality systems, and emerging compliance trends.

Alice Gravereaux holds an Engineering degree in Biotechnology and has over 15 years of Regulatory Affairs experience in the food industry, specializing in EU, Canadian, and US legislation and Codex Alimentarius standards. Before joining RegASK, she worked as a Regulatory Affairs Manager at European (SNE) and International (ISDI) trade associations, representing the dietetic food industries and later as a Nutritional Marketing Specialist for infant formula at Nestlé. After transitioning into consulting in the US, Alice joined RegASK in January 2021 as an expert and became Regulatory Affairs Project Manager in September 2021, focusing on food supplements, infant formula, and novel ingredients.

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