Watch our RAQA Deep Dive session featuring Nicholas Wells, an expert in regulatory strategy and intelligence, as he shares actionable insights and compelling case studies on effectively managing compliance challenges. This engaging session covers a variety of topics, from fostering proactive relationships with regulatory bodies to leveraging innovative technologies for improved risk assessment. You will discover a roadmap designed to empower professionals eager to enhance their regulatory practices and navigate the ever-evolving compliance landscape. Watch the full recording and explore the Key Takeaways and Q&A below!
Theme: "From Data to Insights: Transforming Regulatory Information into Actionable Intelligence"
Expert Speaker: Nicholas Wells
Further down this page, you'll find Key Takeaways, Q&A and other useful resources.
Full Recordings of the webinar
🎙️ Speaker: Nicholas Wells
📚 Theme: From Data to Insights: Transforming Regulatory Information into Actionable Intelligence"
🗓️ When: Oct 10, 3pm CET
⏱️ Duration: 53 minutes
Key Takeaways:
Struggles Due to Lack of Preparation: Nicholas Wells shared a case study illustrating how a company faced significant difficulties due to insufficient preparation for regulatory changes. This led to a frantic scramble to compile necessary data and meet regulatory deadlines, diverting valuable resources and incurring avoidable costs. Companies can prevent such pitfalls by monitoring the regulatory landscape, adhering closely to regulatory guidance from the outset and seeking expert advice when needed.
Successful Proactive Approach: In contrast, Nicholas highlighted a company that successfully navigated regulatory challenges, such as those resulting from Brexit, by establishing dedicated cross-functional teams. This proactive strategy allowed them to avoid delays and seize upon new opportunities, like the MHRA’s International Recognition Procedure rapidly. Their success stemmed from effective regulatory intelligence, consistent monitoring, and adept resource management.
The Importance of a Good Relationship with Regulatory Bodies: Nicholas emphasized that maintaining a strong and proactive relationship with regulatory bodies is crucial for long-term success. Companies perceived as organized and reliable are more likely to have smoother compliance processes. A poor reputation stemming from unpreparedness can complicate future interactions with regulators, making it essential to foster goodwill and trust.
Balancing Proactive and Reactive Approaches: While it's unrealistic to be proactive in every situation, organizations should strive for a forward-looking approach wherever feasible. Implementing systems such as triage frameworks can help prioritize issues effectively, ensuring that companies are better equipped to respond to unexpected regulatory changes when they arise.
Building Flexible Decision Frameworks: With the regulatory landscape evolving rapidly, particularly due to innovations like AI, companies need adaptable decision-making frameworks. These frameworks should facilitate compliance without compromising market timelines. Efficient monitoring, trend analysis, and automation must be paired with clear internal processes that engage cross-functional teams to navigate change smoothly.
Unified Systems for Regulatory Intelligence and Post-Market Surveillance: Nicholas suggested that, where feasible and/or appropriate, organizations should pursue unified systems that integrate regulatory intelligence and post-market surveillance. This approach increases efficiency and fosters a cohesive strategy for compliance and monitoring across departments, mitigating the risks associated with siloed operations.
Evolving Legislation and Technology: One major challenge discussed was the rapid pace of technological advancements, particularly AI, and how legislation and regulatory frameworks often struggle to keep pace. The future of regulatory compliance lies in developing flexible policies that can adapt to these changes while remaining focused on core compliance and safety principles. Companies must be proactive in adapting their strategies to accommodate emerging technologies and evolving legislation.
Leveraging AI Effectively: Nicholas shared practical insights into leveraging AI in regulatory affairs. While AI tools can assist with content creation and analysis, they should not be relied upon exclusively. The nuances of regulatory expertise often require human oversight and input to ensure accuracy and contextual relevance. Organizations should explore how AI can enhance their operations while recognizing its limitations. The discussion also briefly delves into practical strategies for effectively leveraging AI in compliance processes.
Questions and Answers:
Question: How do we ensure that risk classification aligns across multiple regions with different regulations, especially when the change might be high risk in one market but low risk in another?
Answer: Nicholas emphasized the need to consider which markets are affected by the changes. Risk classification may be based on market levels, utilizing a color or number coding system to reflect the risk associated with each market. For example, a change might be classified as high risk (red) in one market or region but medium risk (orange) in another. The process involves breaking down the change by product and market and highlights the importance of expertise and round-table discussion in this classification.
Question: What tools or technologies have you found most efficient in staying ahead of regulatory updates and making faster, accurate risk classifications or decisions?
Answer: Nicholas mentioned a specific tool that has been effective for monitoring sources needed for regulatory intelligence and report generation. He and his team have also created their own classification matrix tool tailored for their needs, which has also been useful for various clients. Nicholas acknowledged that there are many tools available in the market, but their effectiveness depends on whether they meet the specific requirements of the organization.
Question: How do you make use of AI today?
Answer: Nicholas shared that AI assists with content creation and can provide alternative viewpoints on regulatory changes. He mentioned using AI for scenario planning, where he simulates how a change might impact an organization with specific products in various markets. However, he stressed that AI should not be solely relied upon, as it lacks the specialized regulatory expertise that comes from human experience.
Question: What about tools like Perplexity or other AI models?
Answer: Nicholas indicated he has not tried Perplexity but discussed the usefulness of other AI models for scientific purposes. He shared insights on the need for AI tools to provide sources for information, which some models do better than others. He mentioned that while these tools can help with literature reviews, they should not be solely relied upon for regulatory submissions due to potential time gaps in the data they use.
Contact Nicholas Wells on:
LinkedIn: linkedin.com/in/nik-wells-regconsult.
Email: nik@regconsult.co
RegConsult: regconsult.co
RegIntel: regintel.co
Haven't explored AI and smart tools for regulatory affairs yet? Try Hoodin with a 14-day free trial. No credit card required, and it only takes about 15 minutes to see how it can enhance your compliance and surveillance efforts.
Subscribe to our blog to stay informed about upcoming episodes of RAQA Deep Dives and access additional resources, videos, and more