Recap from Kamet Consulting Group's Global Regulatory Operations and Excellence - Leaders Forum

We are still abuzz with excitement following our recent Global Regulatory Operations and Excellence Forum, which saw leaders from a diverse array of life sciences organizations in attendance. A heartfelt thank you goes out to our core team members, Scott Cleve , Susan Uptain, Ph.D. , and Meghan Arthur , whose invaluable contributions helped shape the forum's agenda.

We are also grateful to our partner Gens and Associates Inc. for their collaboration and support.?

With participation from 17 leaders across 16 organizations, we delved into several pivotal topics affecting modern regulatory organizations, focusing particularly on strategies for navigating the influence of emerging technologies such as Gen AI to streamline and automate future processes.

Key highlights from the forum are below:?

• Navigating Regulatory Operations: Balancing Talent and Technology in a Shifting Landscape

In the complex world of regulatory operations, where compliance and efficiency are paramount, navigating the shifting landscape requires a balance between talent and technology. The discussion underscored the challenges faced by both large and small pharmaceutical companies, each grappling with distinct hurdles in data management, technology adoption, and talent acquisition. While automation promises tantalizing efficiencies, concerns loom large over data integrity, ROI and the scalability of new technologies.?

Smaller companies, in particular, struggle to keep pace, hindered by limited resources and a need for upskilling in Regulatory Affairs. Additionally due to lack of scale, it is impractical for them to invest in internal systems. These companies will often use SharePoint or Box as their EDMS, and outsource publishing/dispatch tasks due to a lack of investment in publishing software. This reliance is due to funding challenges and shortages in regulatory and IT personnel.?

Despite these challenges, there is consensus on the importance of prioritizing collaboration and investment in technology infrastructure to drive innovation. Upskilling initiatives, specialized hiring, and ongoing education efforts emerge as crucial strategies to navigate this dynamic landscape effectively. As regulatory operations expand beyond traditional functions, the integration of talent and technology becomes imperative to ensure compliance, quality, and ultimately, patient well-being.

• Bridging the Gap: Addressing Resource Limitations in RIMS Capabilities

The ongoing challenges within the pharmaceutical sector regarding the effective implementation of Regulatory Information Management Systems (RIMS) shed light on various critical issues. While budget constraints and the need for upskilling operational staff to leverage RIMS efficiently were highlighted, there's a deeper dimension to explore, integration of RIMS with other key functions in the ecosystem.?

Integration stands as the cornerstone for realizing the promise of RIMS, offering seamless connectivity and data flow across disparate systems and processes. It's not merely about adopting RIMS but ensuring its harmonious integration with existing frameworks and technologies. This integration fosters a unified system where regulatory data can be efficiently managed, analyzed, and disseminated across the entire system landscape. There was consensus on the necessity for defined skills and strategic alignment within operations to optimize RIMS utilization, but it's imperative to acknowledge that achieving the full potential of RIMS hinges significantly on the realization of seamless integration.

Challenges related to a disconnect between promised capabilities and actual results were discussed, prompting reflections on ROI and the dominance of certain software providers. Despite these challenges, there was optimism about the potential for industry collaboration and the evolution of RIMS to meet the sector's evolving needs. This conversation underscores the complexities involved in RIMS implementation and the importance of strategic adaptation within the pharmaceutical landscape.

• Communicating with cross-functional Leadership: Bridging Regulatory Requirements with Leadership's understanding of Foundational Data Concepts

Participants discussed the challenge of conveying the significance of foundational data concepts, such as accurate data and data governance, to leadership beyond regulatory operations. Without a clear understanding of these foundational data concepts, leadership may not fully appreciate the importance of investing in technologies that ensure data accuracy, integrity, and governance, over launching a new product or line extension.?

As a result, Initiatives aimed at improving Regulatory Information Management (RIM) or implementing Gen AI use cases face significant challenges due to the inadequacy of foundational data. The data in current systems lacks proper structure and accessibility, making it unsuitable for interpretation by next-generation language models required for automation. Without clean and readily available data, the implementation of Gen AI use cases remains hindered, limiting the effectiveness of RIM improvement efforts.

The conversation also emphasized the persistent challenge of a communication gap between teams utilizing various platforms. It highlighted the pressing need for enhanced coordination and a deeper grasp of data governance principles. Moreover, participants emphasized that data models across modules, even those provided by the same vendor for Quality, Regulatory Information Management (RIM), etc., lack standardization. This absence of uniformity results in increased effort required to establish connections between these systems or facilitate seamless communication among them.

The discussion reflected on the historical immaturity of data practices and the task remediation efforts to structure those data. The dialogue stressed the importance of aligning digital use cases with the regulatory process roadmap for meaningful investments, underlining the need to bridge understanding of foundational data concepts between regulatory and non-regulatory leadership. This exchange underscores the critical imperative for effective communication and strategic alignment across organizational hierarchies in implementing foundational data concepts crucial for compliance and success.

• Accelerating Automation: Meeting the Imperative for Advancement in Regulatory Practices

The discussion revolved around identifying submission activities that would benefit most from technology and automation solutions, with a focus on enhancing user experience, streamlining processes, and improving data quality. Forum leaders highlighted several areas ripe for automation, including creating a seamless user experience through chatbots that digest SOPs and job aids, managing post-approval content plans, and automating quality control, translations, and summary creation based on TOC trackers. Emphasis is placed on making the right business case and selecting appropriate automation targets, considering all research and development areas over the next 2-3 years.?

Accurate data and a robust data foundation were identified as crucial precursors to successful automation, with the concept of a Data Fabric proposed as a backbone for automation readiness. Unlike a traditional Data Lake, which primarily focuses on integrated storage and retrieval of data from various sources, a Data Fabric emphasizes end-to-end integration across functional domains. Essentially, a Data Fabric serves as a comprehensive framework that not only consolidates data but also ensures its seamless flow and accessibility throughout the organization's processes and systems. It provides the necessary infrastructure to support automation initiatives by enabling consistent data quality and availability across diverse regulatory activities. To guide leadership in formulating an automation strategy for regulatory activities, a framework is suggested, stressing the importance of education on the relationship between data cleanliness and automation effectiveness within the context of a Data Fabric.

This discussion underscores the strategic approach required to identify, prioritize, and implement automation solutions effectively across submission activities, highlighting the critical role of data quality and organizational readiness.

• From Evolution to Implementation: Evaluating the Relevance of eCTD 4.0

The challenges and progress in implementing eCTD 4.0 was a bustling topic. Participants note the challenges of certain regulatory agencies in implementing eCTD 3.0 correctly and the subsequent efforts by industry stakeholders to advocate for proper implementation through letters and position papers. However, vendors are reported to be lagging in readiness for eCTD 4.0, resulting in two different submission formats. The need for a transition assessment matrix (TAM) to prepare for full eCTD 4.0 implementation is highlighted, alongside considerations about building upon eCTD or exploring alternative formats like XML and PDF files. Examples from forum participants illustrated varying levels of readiness and reliance on external providers. The historical evolution of eCTD versions is outlined, from 2.0 to the draft implementation guide of 4.0. This dialogue underscored the ongoing efforts and complexities in transitioning to updated eCTD standards whilst maintaining compliant submissions, emphasizing the importance of collaboration between industry stakeholders and regulatory agencies to ensure successful implementation.

***********************************************************************************

If you are interested in participating in our next forum, or having a discussion about these topics -- please reach out to [email protected] or you can directly message me on LinkedIn.