The Regulatory Affairs Professionals Society (RAPS) launched its inaugural Global Regulatory Strategy Conference during March 10–12, 2025, in Baltimore, Maryland, under the newly established RAPS Conference Series. The event brought together global regulatory affairs professionals spanning pharmaceuticals, biologics, medical devices, and nutritional products for three days of expert-led sessions, workshops, and strategic networking.
Theme: Mastering Global Regulatory Strategy
With the global regulatory landscape undergoing rapid transformation due to technological innovation and evolving compliance mandates, the conference’s central theme—“Mastering Global Regulatory Strategy”—addressed the need for forward-thinking approaches. Attendees explored frameworks for accelerated product development, market access, and regulatory agility in a complex international environment.
Empowering Regulatory Professionals: Key Topics & Highlights
With over 15 educational sessions, the conference provided both strategic guidance and actionable tools. Topics spanned:
- Clinical evidence and post-certification compliance under EU IVDR (In Vitro Diagnostic Medical Device Regulation)
- Global regulatory intelligence at scale
- AI and automation in regulatory operations
- Therapeutic area–specific regulatory planning models
- Post-market surveillance best practices under EU MDR (Medical Device Regulation)/IVDR
Driving Innovation Through Industry Collaboration
NAMSA, the conference’s principal sponsor, delivered thought leadership on Investigational Device Exemption (IDE) study preparedness, led by Wendy Schroeder, and offered personalized consultations throughout the event. Additional sponsors highlighted how AI and digital tools are transforming regulatory operations:
- Weave Bio showcased its AutoIND platform, demonstrating automation in Investigational New Drug (IND) submissions.
- RegASK presented its AI-powered regulatory intelligence suite, emphasizing early risk identification and proactive compliance.
- QbD Group contributed insights on quality-by-design methodologies, enhancing regulatory strategy alignment.
Key Takeaways from RAPS 2025
- Harnessing AI and Automation to Streamline Regulatory Submissions
Digital transformation was a major theme throughout the event. Solutions like Weave Bio’s AutoIND and RegASK’s compliance intelligence tools showcased how AI can dramatically reduce submission timelines and human error—supporting faster, more reliable market approvals.
- Global Regulatory Harmonization for Market Expansion
Speakers stressed the value of aligning strategies across the US, EU, and Asia-Pacific to facilitate broader and faster product access. Attendees received templates and planning frameworks for consistent, multi-region submissions.
- Agility in an Evolving Compliance Environment
With continuous policy updates, particularly in the EU IVDR and US Food and Drug Administration (FDA) spaces, experts emphasized the importance of regulatory foresight, adaptable post-market strategies, and embedded risk management systems.
- Strategic Collaboration & Cross-Sector Learning
The event created a vibrant platform for peer-to-peer learning, with applied workshops that enabled participants to simulate real-world regulatory scenarios and problem-solving strategies. Informal networking further enriched collaboration opportunities across organizations and geographies.
- Accelerating Product Development with Practical Frameworks
Tools introduced by NAMSA, particularly in transitioning from product development to pivotal IDE studies, resonated strongly with attendees. Applied case studies and readiness strategies provided a roadmap for shortening time-to-market without compromising on quality or compliance.
Looking Ahead: A Blueprint for Regulatory Success
The RAPS Global Regulatory Strategy Conference 2025 set the tone for a future defined by technology-enabled compliance, multinational harmonization, and strategic collaboration. As companies strive for efficiency and agility, regulatory professionals will play a pivotal role in shaping pathways that align innovation with safety and compliance.
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