3 Regulatory Affairs Professionals Society
Introduction
Over the last 30 years, regulatory intelligence (RI) has
grown from a new concept to a key component of regulatory
affairs. As more information became publicly available and
regulatory science advanced, using data and insights from
the regulatory landscape has become standard in business
decisions. This is especially important for regulatory affairs
professionals working on the research and development of
drugs, biologics, medical devices, and digital health tech‑
nologies. RI programs aim to support the timely, informed
decisions needed to deliver safe and effective medical prod‑
ucts to patients.
Even though RI is now a core skill, the types of activities
and roles involved can vary significantly from one company
or person to another. At the RAPS (Regulatory Affairs
Professionals Society) Regulatory Intelligence Conference1
held in Baltimore, Maryland, in March 2025, this variety
was clear in both the topics discussed and the backgrounds
of attendees. Some attendees came from regulatory policy
perspectives with backgrounds in trade associations and
agency surveillance. Others came from a regulatory strategy
perspective with backgrounds in product development and
interfacing with regulatory agencies on clinical development
programs and labeling negotiations. Still others came from
backgrounds in quality assurance, pharmacovigilance, change
management, good practices compliance, and audit prepara‑
tion. While everyone uses public information from agencies
like the US Food and Drug Administration (FDA) and the
European Medicines Agency (EMA), they often use it in
different ways and may not always agree on what RI means.
These differences can make it harder to work together on RI
projects or see the whole RI picture across an organization
(Figure 1-1).
Looking back on the conference and the range of
perspectives in the RI community, it is clear that a unified,
general framework is needed for all RI activities in medical
product research and development. The General Framework
for Regulatory Intelligence in Medical Product Research
and Development (R&D) introduced in this chapter aims
to provide a shared language for discussing RI concepts and
a way to assess your team’s or vendor’s RI capabilities. Most
importantly, this framework is designed to be flexible and
adaptable to your needs. Feel free to discuss, challenge, and
adjust it to fit your organization.
Background
RI is not a department or job title. While some teams and
professionals have “regulatory intelligence” in their titles,
many people perform RI work without it being explicitly
mentioned in their roles. Before outlining a framework, let
us examine some regulatory affairs roles in medical product
organizations that often involve RI activities, even if not
explicitly labeled as such. The exact roles and responsibilities
may differ in your organization, but these examples show the
range of teams involved in RI.
1 A General Framework for Regulatory
Intelligence in Medical Product
Research and Development
Chris Whalley
Figure 1-1. Different Perspectives on Regulatory
Intelligence
It’s about
compliance
It’s about
product
strategy
It’s about
safety
reporting
Introduction
Over the last 30 years, regulatory intelligence (RI) has
grown from a new concept to a key component of regulatory
affairs. As more information became publicly available and
regulatory science advanced, using data and insights from
the regulatory landscape has become standard in business
decisions. This is especially important for regulatory affairs
professionals working on the research and development of
drugs, biologics, medical devices, and digital health tech‑
nologies. RI programs aim to support the timely, informed
decisions needed to deliver safe and effective medical prod‑
ucts to patients.
Even though RI is now a core skill, the types of activities
and roles involved can vary significantly from one company
or person to another. At the RAPS (Regulatory Affairs
Professionals Society) Regulatory Intelligence Conference1
held in Baltimore, Maryland, in March 2025, this variety
was clear in both the topics discussed and the backgrounds
of attendees. Some attendees came from regulatory policy
perspectives with backgrounds in trade associations and
agency surveillance. Others came from a regulatory strategy
perspective with backgrounds in product development and
interfacing with regulatory agencies on clinical development
programs and labeling negotiations. Still others came from
backgrounds in quality assurance, pharmacovigilance, change
management, good practices compliance, and audit prepara‑
tion. While everyone uses public information from agencies
like the US Food and Drug Administration (FDA) and the
European Medicines Agency (EMA), they often use it in
different ways and may not always agree on what RI means.
These differences can make it harder to work together on RI
projects or see the whole RI picture across an organization
(Figure 1-1).
Looking back on the conference and the range of
perspectives in the RI community, it is clear that a unified,
general framework is needed for all RI activities in medical
product research and development. The General Framework
for Regulatory Intelligence in Medical Product Research
and Development (R&D) introduced in this chapter aims
to provide a shared language for discussing RI concepts and
a way to assess your team’s or vendor’s RI capabilities. Most
importantly, this framework is designed to be flexible and
adaptable to your needs. Feel free to discuss, challenge, and
adjust it to fit your organization.
Background
RI is not a department or job title. While some teams and
professionals have “regulatory intelligence” in their titles,
many people perform RI work without it being explicitly
mentioned in their roles. Before outlining a framework, let
us examine some regulatory affairs roles in medical product
organizations that often involve RI activities, even if not
explicitly labeled as such. The exact roles and responsibilities
may differ in your organization, but these examples show the
range of teams involved in RI.
1 A General Framework for Regulatory
Intelligence in Medical Product
Research and Development
Chris Whalley
Figure 1-1. Different Perspectives on Regulatory
Intelligence
It’s about
compliance
It’s about
product
strategy
It’s about
safety
reporting