I recently had the opportunity to participate in the 2024 Drug Information Association (DIA) Regulatory Submissions, Information and Document Management (RSIDM) Forum held in North Bethesda, Maryland. In this blog post, I’ll share my insights and key takeaways from the conference, as well as practical tips for future attendees.

Background

The Drug Information Association (DIA) is a diverse network of life science professionals facilitating expert knowledge sharing, innovative concepts, and collaborative networking and discussions centered on advancing patient health and well-being.

Rooted in establishing trust, integrity, and treating people with respect, the DIA strives to create an impartial platform, and host events that facilitate knowledge sharing and professional growth for individuals in the biotechnology, pharmaceutical, medical device, and affiliated industries.

The Regulatory Submissions, Information and Document Management (RSIDM) is a specialized DIA conference catered to the latest trends, innovations, and best practices within our industry. Health authorities and regulatory stakeholders examine current and future data standards, requirements, and effective regulatory information management strategies.

Sessions are structured throughout the conference providing invaluable insights on how to build and sustain successful RSIDM systems, how to improve on current processes and procedures, adopt innovative technologies, and how to reach regulatory success. These forums provide annual opportunities for networking, knowledge sharing, and education for both business and technology focused attendees at all levels.

The DIA RSIDM also hosts a hall for exhibitors and sponsors, case study spotlight sessions, and pre-forum virtual short courses for attendees.

Conference Highlights

Keynote – Fostering Trustworthy and Responsible AI

The 2024 DIA RSIDM was focused on Artificial Intelligence (AI), a reoccurring hot topic within our industry. This year the Keynote Speaker Reggie Townsend, Vice President of Data Ethics for SAS, led the DIA RSIDM on how the AI interface is new, the ability is novel, but assured that we have been using these services and capabilities for years. It just feels different.

The aim is to build and sustain AI that reflects our values as a society, especially within regulatory. Preserving employee dignity, structuring and controlling how AI may influence our regulatory practices is crucial. To ensure ethical AI usage, we must shift the focus from, “Can we”‘ to ”Should we?'”

Health Authority Updates

Health authority representatives are given a platform to provide current updates from their respective divisions. For the FDA, updates centered around eCTD 4.0, and an eSub forum going over top 2023 eCTD rejections, CBER’s new automatic rejections if technical criteria are not met, other common submission errors, and a Q&A space for attendees.

The FDA also discussed future plans to transition eCTD to a more structured data format, similarly to Pharmaceutical Quality – Chemistry, Manufacturing & Controls (PQ/CMC). This would allow submissions to be automatically ingested without the needs for manual transposition and allowing consistent data to be reviewed via AI assisted analytics. Structured data also echoed in the FDA’s protocol template update, emphasizing harmonized structured data for ease of review, i.e., searchable content and machine readable. The move to structured data also affects pre-market reporting to FAERs, where new XMLs would allow machine readability, immediate acknowledgments, and the ease of sending safety reports directly from a database.

There was also update on the Electronic Signature Gateway (ESG), and how a new ESG version will transition in Q4 2024 – Q1 2025. Key updates will include web-based step-by-step submission system, eSignatures will replace digital certificates, and 1 TB size submissions. Communication and roll out plans are in effect and more information can be found on the CDER ESG website.

There were also insightful technical, AI and automated theme updates from international health authorities:

• MHRA (UK) – RegulatoryConnect switching to a cloud based platform.
• Health Canada (HC) – incorporating AI, automation within the Health Products and Food Branch (HPFB) but emphasizing that people, not AI, would remain as decision makers
• IDMP (EU) – Key system updates, and AI activity updates focused on collaborative reflection papers, workshops, guidances, and proposed legislations
• eCTD Implementation (APAC) – impressive overview of APAC countries and their acclimation toward eCTD harmonization.

DIA RISDM Tracks

This year’s forum provided 27 educational sessions with 90+ diverse speakers from regulatory, industry and academia. These sessions were broken up into four distinct tracks:

• Track 1: Building and Sustaining Successful RSIDM Foundations
• Track 2: Optimizing Processes and Procedures
• Track 3: Adopting Innovative Technologies
• Track 4: Achieving Regulatory Excellence

I attended Track 1: Building and Sustaining Successful RSIDM Foundations, focused on staying compliant with current state of affairs, sharing day-to-day processes, and case studies. One of the key sessions of Track 1 was on eCTD 4.0 – Paving the Path for Streamlined Global Drug Submissions. It consisted of three presentations – a comprehensive eCTD 4.0 overview, an in-depth exploration of technical standards and metadata, and a case study regarding the PMDA (Japan) eCTD 4.0 technical pilot. This was an excellent session that catered to all levels and encouraged opportunities to seek agency feedback, evaluate eCTD 4.0 software, and gain business insights for future submissions.

Tips for Attending

If you’re considering attending the RSIDM Forum next year, or any future DIA event like DIA 2024, here are some helpful tips to maximize your experience:

Tip 1: Research and Plan

Take the time to review the conference agenda. If you are attending with colleagues, consider discussing and assigning sessions beforehand to optimize your time at the conference.

Tip 2: Come Prepared

Bring multiple forms of note-taking materials. While laptops are convenient, consider bringing more than one form of note taking material such as a notepad and pen in case of technical issues.

Tip 3: Take Notes

Although presentation slide decks are provided to attendees, they may not comprehensively capture all the information or points discussed by the speaker. Additionally, video recordings are not allowed, so be prepared to take detailed and comprehensive notes.

Tip 4: Engage

Make the most of networking opportunities by exchanging business cards and utilizing the DIA conference app. The app offers access to the agenda, social networking features, and Q&A sessions, allowing you to engage with presenters without needing to physically approach the microphone.

Tip 5: Present and Share

Consider creating a presentation to share with your colleagues who could not attend the conference. This will allow you to update and share with them the key takeaways and highlights of the conference.

Take Away

The 2024 DIA RSIDM conference offered a wealth of insights and updates on regulatory practices, AI integration, and industry advancements. From keynote discussions on ethical AI usage to practical sessions on eCTD 4.0 and regulatory compliance, attendees gained valuable knowledge and networking opportunities. Although the in-person conferences can be overwhelming, I found the face-to-face interactions at DIA RSIDM to be incredibly beneficial. It was refreshing to connect with our industry in‑person, learn the latest directly from health authorities, and to understand the work of regulatory professionals in other fields. It was also a great experience to interact with health authority representatives in person, rather than solely through email and virtual means.

Overall, the RSIDM conference served as a valuable platform for not only me and colleagues who could attend, but also for my Regulatory Operation team. Our Regulatory Operation associates ensure compliance through the latest guidances, insights, solutions, and maintaining valuable information within our group.

Discover how Premier Consulting’s expert Regulatory Operations team can support your success. Contact us today!

Author: Yasmin Rodino, Senior Associate Regulatory Operations

Special Thanks to: Craig Shaw, Regulatory Operations Associate III and Jorge Sierra, Regulatory Operations Associate III