Modular content, as we all know, is an approach that allows organizations to create marketing materials by combining pre-approved content blocks or modules. While a modular content approach brings efficiency and flexibility into the content creation process, the final accountability of compliance is still with the regulatory teams. The regulatory reviewers are responsible for ensuring adherence to policies, guidance, documents, and regulations set under the Code of Federal Regulations. They play a crucial role in ensuring fair balance, proper substantiation of claims, and partnership with R&D to ensure that the right evidence is presented.
In a panel discussion hosted by Jeremy Richter, Senior Director of MLR and Content Strategy at Indegene, four industry leaders in the regulatory and promotional material review space discussed the role of regulatory advertising and promotional (RAP) content review teams in the transformation journey toward modular content. The panel included
The panelists addressed the challenges and impact of the modular content initiative, and change management considerations from a regulatory standpoint.
Here are some of the key takeaways from the webinar:
Craft regulatory business rules, around modular content, meticulously to ensure compliance
The process of creating modular content requires organizations to build internal processes that will help structure the content and ensure that evidence traceability stays intact. To be compliant, modular content must be underpinned and governed by strict regulatory business rules that dictate what can and cannot be used together. This requires a cultural and mindset shift and imbibing a process discipline upfront, and training authors and reviewers to leverage modular content to their benefit. In addition, starting with a robust and up-to-date claims database is essential, as it forms the basis for building the framework for modules and processes.
Modularization, especially of high-risk claims content can be challenging considering the possible repercussions from non-compliance. Also, risk level perception can vary across organizations and local regulations. Companies need to make their risk determinations based on their culture and capabilities. A tiered system for claims that can be modularized makes it easier to prioritize reviewer effort; for example, low-risk claims that are easier to assess might need minimal to no manual intervention. That said, the focus should be on building business rules around claims instead of categorizing them as high or low risk. The adaptability of data and the different formats of content can also play a huge role while defining business rules. For example, the nature of digital assets, such as social media platforms, changes constantly and affects the functionality and dynamic of the content, making it difficult to create business rules around them. The business rules need to be built for modular and intra-modular content-oriented rules that include disclaimers, footnotes, and channel-specific formats. Therefore, the regulatory view function plays a crucial role in keeping up with these changes and ensuring fair balance and substantiation of claims.
Leadership alignment and cross-function collaboration are key in the modular content journey
Change management can be challenging unless leaders across the organization are aligned on the ultimate goal and ensure that everyone is heard in the process, including the reviewers and frontline reviewers. While the commercial function typically leads the effort on content creation, organizations must recognize that the MLR teams are the key stakeholders, and their involvement upfront is critical for success. The IT infrastructure-related aspects must also be considered, such as the platforms and tools used to store modules and create derivative assets.
The level of risk that a regulatory reviewer sees with a process or change becomes crucial, especially considering regulatory compliance. For example, FDA has not issued any clear communication about modular content. The FDA will require the submission of all components of the modular content, and organizations need to ensure that the content meets the regulatory requirements. Additionally, organizations need to provide clear documentation of how the modules can be combined to form different assets and how they will be reviewed for compliance. Verification will always be necessary to maintain regulatory compliance and build confidence in the model.
Overall, change management must be taken care of at every stakeholder's level, and a disciplined process should be in place for everyone to get comfortable with the new practice.
Artificial intelligence (AI) can enhance the adoption of modular content
AI can increase reviewers’ confidence in machine-assembled content. For example, if the machine tells a reviewer that 100% of the business rules were followed and the content was pre-approved, it would make the review more efficient and less scrutinized than if it were reviewed by a human. However, there needs to be a level of trust in the machines, and building processes and controls to effectively utilize AI is important. AI could add to the validation process of complex IT systems, and complementary internal processes can help build that confidence in AI.
In conclusion, while modular content has the potential to bring efficiency and flexibility to the content creation process, the pharma has to ensure that the materials are complying with regulatory guidelines and restrictions. Organizations must build internal processes and develop a cultural mindset shift to ensure that evidence traceability stays intact and comply with regulatory requirements. This requires leadership alignment and cross-functional collaboration, including involvement from regulatory and promotional reviewers upfront. AI has the potential to make reviewers more confident in machine-assembled content, but there needs to be a level of trust in the machines and building processes and controls to effectively utilize AI. In summary, modular content can be successful if it is underpinned and governed by strict regulatory business rules and incorporates changes in technology and regulatory requirements to maintain compliance.
You can access the webinar here for more insights: https://www.indegene.com/what-we-think/videos/webinar-key-considerations-for-regulatory-advertising-and-promotion-rap-in-the-transition-towards-modular-content