Insights from the Regulatory Customer Forum: Turning Regulatory Intelligence into Action

Recently, the InfoDesk team hosted our second customer forum for regulatory intelligence professionals in the pharmaceutical and medical device sectors. 

The forum was hosted by Chris Whalley, Senior Director and Head of Global Regulatory Intelligence & Analysis at Pfizer, and featured insights from Norbert De Clercq (GSK), Karen Ragland (Otsuka), and Louis Ginn (AstraZeneca). 

These experts shared valuable insights on how their organizations leverage the InfoDesk platform to ensure the right information reaches the right audience, while maintaining consistent branding and accessibility. 

Key topics included communication strategies, platform customization, cross-departmental collaboration, and monitoring methodologies.

You can watch the full video by clicking the image below: 

Strategic Communication Approaches

First, our panelists discussed how they have adopted the InfoDesk platform to fit their unique needs, delivering critical intelligence to the right audience in the right way. 

Otsuka has developed a branded newsletter called "The Grid" (Global Regulatory Intelligence Digest), which is distributed to over 700 employees through multiple weekly editions, focusing on health authorities and regulatory guidelines. They also release a monthly trade association edition, focusing on trade industry news.

Otsuka also commented that, “in the dynamic landscape of regulatory affairs, our Regulatory Intelligence team plays a crucial role in supporting various departments by providing insights into regulatory precedents, health authority requirements, and approval processes.

“We respond to complex ad hoc queries from our Regulatory Strategy team and other stakeholders, addressing topics such as regulatory precedents, approval package details, label claims, and background regulatory information.”

Beyond answering inquiries, they also contribute to strategic planning by leveraging historical regulatory data to anticipate challenges and streamline approval pathways. 

Additionally, they coordinate responses to regulatory guidances and Federal Register notices by organizing response teams, engaging with subject matter experts, and ensuring structured feedback to regulatory agencies. By continuously gathering, analyzing, and disseminating regulatory intelligence, their use of the InfoDesk platforms empowers the organization with the knowledge needed to navigate the evolving regulatory landscape effectively.

AstraZeneca takes a slightly different approach as their Regulatory Intelligence teams operate with a focus on Therapeutic Area responsibilities. Their newsletters and alerts cover each of these different areas, capturing broader scope information and filtering it down to their Regulatory Strategy teams. They also maintain specialized publications for CMC and selected Health Authority highlights. 

Finally, GSK has branded their platform as "Ricardo" and currently have more than 1,000 subscribers across three main information categories: regions/geographies, specific topics, and therapeutic areas. 

But they also get even more granular, encouraging team members to access the platform themselves and set up personal alerts if they want to monitor specific regulatory areas personally and promptly.

Platform Adoption and User Engagement

The panelists also shared their strategies for ensuring effective platform adoption. 

For example, GSK created bite-sized training videos on using the platform, as well as instituting quarterly webinars to verbally review the most important topics, whilst always linking back to Ricardo.

At AstraZeneca, they put emphasis on regular feedback from their internal communities, not only to ensure that they are capturing the right information, but also that they are distributing it at the right cadence.

Louis discussed how he had implemented this strategy for teams working on their gene therapy products, asking them to participate in “an interactive session to put in keywords they’d like to see across all of the different pieces of news that are coming out.”

Finally, Otsuka has implemented a system to ensure that specific information gets to key stakeholders. 

Karen described how she personally reaches out to the owners of internal SOPs when a new guidance document is released, as well as bringing these topics to discuss verbally at global regulatory affairs staff meetings. 

Otsuka have also set up a specialised Japanese edition of The Grid and an InfoDesk portal for their colleagues in Japan, improving their access to mainline regulatory intelligence and enabling them to set up their own specialised newsletter. 

Cross-Departmental Integration

An emerging trend is the extension of the InfoDesk platform beyond regulatory intelligence to other departments. 

GSK has recently launched "iSafety" dedicated to pharmacovigilance intelligence, with a specialized approach for collecting, scoping, and categorizing PV-relevant information.

Several panelists noted growing interest from pharmacovigilance, marketing, sustainability, and quality departments within their organizations. This demonstrates the platform's versatility and ability to serve diverse information monitoring needs.

If you would like to learn more about how your organization can use the InfoDesk platform to improve your Regulatory Intelligence monitoring capabilities, request a meeting with the team. 

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