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03 Oct 2023
Regulatory Affairs in the life sciences industry involves navigating complex regulatory frameworks to ensure compliance with laws and standards governing pharmaceuticals, medical devices, and biotechnology products. This multifaceted field encompasses activities such as product registration, quality assurance, and interactions with regulatory agencies. Staying updated with industry trends is crucial for professionals in Regulatory Affairs as it enables them to anticipate and adapt to evolving regulations, technological advancements, and market dynamics.
If you missed the Veeva R&D Summit this past Sept, I'd like to rewind the clock and transport you right into the heart of this event. Held at the Boston Convention Centre from September 12th to 14th, the event drew approximately 2000 professionals, uniting regulatory enthusiasts, industry leaders, and visionary partners. Across four specialized tracks – Clinical, Regulatory, Safety, and Quality – attendees were treated to a feast of customer presentations, capability demos, innovation theatre sessions, and supplier showcases.
Sparks of Innovation in Regulatory Affairs
Venturing through the Veeva Summit, I naturally focused my attention on the Regulatory Affairs track and found myself surrounded by discussions on the future of regulatory affairs. Topics ranged from Health Authority (HA) queries to Publishing, eCTD 4.0, global-to-local dossier management, and active dossier management. Most notably, Publishing emerged as a shining star, showcasing Veeva's commitment to innovation. In a mere six months, the Veeva Publishing module processed a staggering 70,000 submissions, producing an impressive 4,800 files, 2.7 million hyperlinks, and 1.85 million bookmarks. For regulatory professionals, these developments signify the need to embrace innovation fully, remaining vigilant in staying updated with the latest technologies and tools within the regulatory affairs landscape. Embracing innovation isn't just an option; it's a pathway to enhanced efficiency, precision, and effectiveness in overseeing regulatory processes.
Veeva RIM: A Game-Changer in Regulatory Landscape
Veeva's Regulatory Information Management (RIM) took the spotlight, revealing its pivotal role in transforming the regulatory landscape. As an industry trailblazer, Veeva RIM boasts an impressive client base of over 350 in the regulatory domain. With three annual releases dedicated to enhancing Compliance, Productivity, and User Experience, Veeva RIM proves its dedication to innovation. Industry leaders shared insights on well-managed migration, rollout, and adoption strategies. While Veeva RIM's rapid growth and dedication to innovation are commendable, this development raises some important considerations:
1.
The importance of embracing technology
2.
Internal adaptation for effective utilization of new technology
3.
Well-managed migration
4.
Consideration for external help
The Future of Submissions Planning, Regulatory Intelligence, and Regulatory Writing with AI
With Veeva's focus on submissions specific templates and ability to compile submissions, the potential for Structured Content Automation using Generative AI to support regulatory writing becomes an area that is currently not discussed or tapped into yet through Veeva. Veeva's active API, however, holds the promise of streamlining content automation and providing efficient solutions. Veeva excels in several areas; however, some aspects, like submission-level planning and regulatory intelligence are not priority on their roadmap, necessitating collaboration with partners. One can use Veeva's active API for integrated capabilities by combining it with regulatory intelligence to harness the power of Structured Content Automation and better submissions planning. To prepare for changes being implemented, however, life sciences organizations should prioritize the following top three steps:
1.
Assessment and Planning
Evaluate Needs: Identify the opportunity, e.g., content generation, formatting, and quality control.
Select Solution: Choose a solution matching your needs and budget.
Define Objectives: Clearly state goals like efficiency, accuracy, and faster submissions.
2.
Integration and Implementation
Integration Planning: Seamlessly integrate into existing systems.
Training and Adoption: Encourage user adoption through demos and sandbox exposure
Pilot Implementation: Test on a smaller scale initially.
3.
Monitoring and Continuous Improvement
Performance Metrics: Establish KPIs for efficiency, accuracy, and compliance.
Feedback and Iteration: Use feedback to refine AI continuously.
Stay Informed: Keep updated on AI and regulatory tech advancements.
Generative AI has certainly demonstrated a transformative potential for content, which is planned to become an integrated capability Indegene provides in submission through Veeva. For a deeper dive into Gen AI in Regulatory Affairs, explore my recently hosted webinar: 'Introducing Generative AI in Regulatory Affairs: From Hype to Practical Applications.' You can also delve into the topic by reading a dedicated blog post.
Embracing Data-Driven Regulatory Insights
At the heart of the Veeva Summit was the realization that the future of regulatory affairs lies in data-driven insights. The event showcased Veeva's commitment to this vision through innovation workshops, discussions on eCTD 4.0, IDMP, PQ CMC, and other data-centric demands. The additional experiences Indegene has had in areas such as ePI, CMC, labeling, and others through Vulcan Gravitate, Accumulus, and other industry bodies are all complementary to Veeva's discussion and will further advance the data-centric focus in Regulatory leading into 2024. With experienced partners demonstrating the platform and offering support, Veeva is well-prepared to lead the way in delivering data-centric solutions to the industry.
Regulatory Affairs of the Future
It was an impressive three days at the Veeva Summit. Veeva's Regulatory Information Management platform has gained extensive adoption and continues to evolve, with a strong focus on compliance, productivity, and user experience. While challenges persist in areas like submission-level planning and regulatory intelligence, Veeva's commitment to innovation and partnership, particularly in Generative AI, provides a promising outlook for the future of regulatory affairs. While we eagerly await next year's Veeva summit, feel free to contact me for in-depth discussions on Generative AI, Structured Content Automation, Submissions Planning, Regulatory Intelligence, or any other topic covered in this blog.
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