Gens and Associates - 2020 World Class RIM - Organization

This video provides an in-depth review of Section 2, "Organization Background and Strategies," from the 2020 World Class RIM (Regulatory Information Management) survey conducted by Gens and Associates. The primary goal of this section is to establish baseline organizational data regarding the structure, size, and reporting relationships of regulatory functions within life sciences companies. By collecting this data, the survey aims to facilitate comparisons of organizational strategies, particularly concerning efficiency and the operational models of dedicated RIM groups. The speaker, Steve Ganz, guides participants through key questions related to internal regulatory headcount and the specific remit of dedicated RIM teams.

The analysis begins with Question 7, which focuses on internal regulatory headcount. This question seeks to quantify the number of regulatory personnel across various locations, including headquarters, regional offices, local offices, and other locations. For medical device companies, the terminology expands to include business divisions and design centers. A significant addition to the 2020 survey is the inclusion of an estimated non-employee headcount. This modification aims to capture the total size of the regulatory organization, allowing for a clear split between full-time employees and external resources like contractors, consultants, and temporary staff, expressed as a full-time equivalent (FTE). The speaker notes the potential difficulty in quantifying non-employees, especially those involved in broad service contracts, and clarifies that the focus is only on those external resources that can be reasonably quantified as FTEs.

The second major focus area highlighted is the exploration of the dedicated RIM group, following up on a similar question from the 2018 survey. This section moves beyond simply asking if a dedicated group exists (yes/no/planned within two years) to exploring the specific "remit" or purpose of the Regulatory Information Group (RIG) or team. The speaker emphasizes that this group does not necessarily imply a centralized function; it can be distributed globally, and its size can range from a single individual in small organizations to ten or more in larger enterprises. The survey provides multiple rows listing various potential responsibilities for the RIM group, requiring participants to scale their response based on whether the activity is the sole responsibility of the group, a shared responsibility with another organizational unit, or an area that is not currently managed but is anticipated within the next two years. This detailed breakdown allows for a nuanced understanding of how RIM functions are scoped and managed across the industry.

Finally, the speaker stresses the importance of accurately defining the scope of the RIM group's responsibilities. The survey uses a structured scale to capture whether a function is the sole responsibility of the RIM group or shared with another group, regardless of whether the RIM group is primary or secondary. A crucial element for capturing comprehensive data is the inclusion of an "other" field, allowing participants to manually add responsibilities that are primary to their RIM group but not listed in the predefined options. This mechanism ensures that the survey captures the full spectrum of RIM activities, providing a robust dataset for benchmarking organizational strategies and efficiency comparisons.

Key Takeaways: • Holistic Regulatory Headcount Measurement: The 2020 survey introduced the requirement to estimate non-employee headcount (contractors, consultants, temps) quantified as Full-Time Equivalents (FTEs), moving beyond internal employees to capture the true scale and resource allocation of the total regulatory organization. • Organizational Strategy Benchmarking: The primary objective of collecting organizational data (headcount, structure, reporting) is to establish a baseline for comparing different organizational strategies, particularly in relation to efficiency metrics explored elsewhere in the World Class RIM survey. • Geographic Distribution of Regulatory Staff: Internal regulatory headcount is segmented by location (headquarters, regional, local, other), acknowledging the global nature of regulatory operations and the specific terminology used by medical device companies (business division, design center). • Defining the RIM Group's Remit: The survey shifts focus from the mere existence of a dedicated RIM group to defining its specific purpose and scope of responsibility, which is critical for understanding operational models and resource deployment. • RIM Group Structure Flexibility: The concept of a "dedicated regulatory information group" is flexible; it does not mandate a central structure and can be distributed globally, accommodating organizations ranging from very small teams (one person) to large, multi-functional units. • Quantifying Shared Responsibilities: The survey utilizes a specific scale to distinguish between functions that are the sole responsibility of the RIM group and those that are shared with other groups in the organization, providing clarity on cross-functional dependencies. • Future Scope Planning: Participants are asked to identify areas that are not currently under the RIM group’s responsibility but are anticipated to be within scope in the next two years, offering insight into strategic planning and future technology needs. • Exiting Non-Applicable Questions: A mechanism is provided for required questions (marked with an asterisk) to be exited if they do not currently apply to the organization's situation or are out of scope, ensuring data accuracy and avoiding forced responses. • Customizing Responsibility Capture: The inclusion of an "other" field is vital for capturing unique or specialized responsibilities where the RIM group holds primary accountability, ensuring the survey accurately reflects the diversity of RIM functions across the industry.

Key Concepts:

• RIM (Regulatory Information Management): The systematic management of all information and processes related to regulatory compliance, submissions, and product lifecycle within the life sciences industry.
• Dedicated RIM Group: A specific team or organizational unit tasked primarily or solely with managing regulatory information and related processes, which can be centralized or distributed.
• FTE (Full-Time Equivalent): A unit of measure used to express the workload of an employed or contracted person in a way that makes workloads comparable across various contexts, often used to quantify contractors and consultants.
• Remit: The area of authority or responsibility assigned to a specific group or committee, in this context, defining the specific tasks and functions of the dedicated RIM group.