This February, DIA RSIDM 2025 returns to Bethesda, MD, reaffirming its reputation as the premier event for regulatory professionals to exchange the best solutions for managing complex regulatory submissions. At fme, we specialize in helping pharmaceutical and biotechnology companies navigate regulatory challenges with expertise in selecting, planning, and migrating to RIM solutions tailored to their unique data, documents, and workflows. Visit us at Booth #315 during the RSIDM forum—we’d love to discuss your challenges and plans for 2025!

Operational Efficiency is Critical

Every day, pharmaceutical companies strive to demonstrate the efficacy of new discoveries and deliver life-changing medications to patients in need. To accelerate time-to-market and ensure safety, timely and high-quality regulatory submissions to health authorities are critical for review and approval.

However, the process is fraught with challenges. The sheer volume and complexity of data, documents, and information exchanged among multiple stakeholders and systems create significant hurdles in maintaining accurate, up-to-date documentation. Errors, omissions, or inconsistencies can lead to costly delays and disrupt expected release timelines.

Seasoned regulatory professionals recognize the importance of operational efficiency in managing regulatory information effectively throughout the development cycle, ensuring smooth and successful submissions.

Keys to RSIDM Efficiency and Success

Efficiency and success in regulatory operations depend on seamlessly aligning people, processes, and technology throughout a medication’s journey—from conception to patient use. With years of experience and a proven track record, fme has gained deep insights into the complexities of every phase of this journey. This expertise has enabled us to develop and refine methodologies that:

• Analyze existing systems and workflows
• Align requirements with tailored technology solutions
• Ensure data and documents are accurately classified for discovery and use

fme’s experts combine a deep understanding of the product development lifecycle with extensive experience in regulatory projects. Staying ahead of evolving data standards, requirements, and technology trends, we guide clients toward the best solutions for today while future-proofing their decisions to deliver long-term ROI.

Download this overview to see how fme can help you achieve regulatory excellence and why we are recognized as a leader in content management solutions for regulatory environments.

Connect with fme at DIA RSIDM 2025

Last year, fme’s David Gwyn spoke on “Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools.” This presentation focused on the latest EDM Structured Reference Model team developments, showcasing how their work influences industry-wide adoption. For more information, view the full details of the session here.

For 2025, David will be joined by RIM experts Jonathan Byars and Frank D’Entrone to provide their expertise on effective strategies to align people, processes, and technology for RIM success. fme’s experience across platforms, industries, and global territories gives us unparalleled insights into the best strategies and solutions and how to ensure a successful journey to regulatory excellence.

What are your challenges for 2025? Use the form below to request a no-cost discovery session and we’ll schedule a time to discuss your concerns and possible solutions. If you are attending RSIDM 2025, join us at Booth #315 and we can start the conversation in person! If you can’t attend this year, download the overview and let us know if you’d like to talk.

The DIA RSIDM 2025 Educational Tracks

The educational tracks for this year’s conference reflect the continued integrated communication challenges regulatory professionals face within a quickly evolving technology landscape. Download the overview above to learn more about how we can support your team in each.

• Track 1: Building and Sustaining Successful RSIDM Foundations
  • This track is designed for attendees who are either new to the field or seek a comprehensive review of the evolving dynamics and intricacies that shape their day-to-day work.
• Track 2: Optimizing Processes and Procedures
  • This track is tailored for intermediate-level professionals and focuses on what is needed to improve processes, procedures, and data to foster a culture of innovative practices and forward-thinking. Learn proven industry best practices and discuss the impact of new global regulations on your organization’s processes and procedures.
• Track 3: Adopting Innovative Technologies
  • This intermediate to advanced track provides first-hand knowledge from global regulatory health authorities on the implementation of new technologies, policies, and guidelines. It also includes perspectives on how to incorporate technology advancements like artificial intelligence and automation, and how to assess their effectiveness and impact.
• Track 4: Achieving Regulatory Excellence
  • This advanced track is designed for leadership roles, and includes examples and use cases from organizations that have achieved regulatory excellence. It covers a wide range of practical implementation strategies to support vision, cultural change, and commitment to innovation.

We are excited to participate in these valuable conversations with regulatory thought leaders and re-connect with industry colleagues! Find the full RSIDM 2025 agenda here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!