Regulatory Intelligence Reimagined
7 Regulatory Affairs Professionals Society
For each agency or organization you are following, here
are some examples of the types of information RI programs
can involve:
• Agency regulations and policies
• Guidance for industry
• Regional and international standards
• Product approvals, safety changes, and assessment
reports
• Meeting announcements and
• Publications by agency authors (interviews, conference
presentations, journal publications, etc.)
Once the areas of interest are defined, establishing primary
and secondary sources of intelligence is essential for gather‑
ing comprehensive and reliable information. Primary sources,
such as agency websites, public meetings and workshops,
agency-authored publications, and internal team experi‑
ences, provide firsthand insights and data. Secondary sources,
including media reports, commercial database providers,
trade associations, and consortia reports, among others, offer
valuable context and background information. For most orga‑
nizations, it is unlikely that a single source of information will
provide all the information you need. By leveraging multiple
sources, organizations can build a robust foundation for their
RI program.
Once primary and secondary sources of information are
established, continuously monitoring and scanning them is
vital for staying current with the latest developments and
trends. This proactive approach involves regularly reviewing
new and revised information to ensure accuracy and consis‑
tency. The frequency and depth of monitoring will depend
on the size and skills of your team, as well as the technology
used. By continuously monitoring your sources, organizations
can quickly identify emerging opportunities, potential threats,
and shifts in the regulatory landscape, enabling them to
respond swiftly and effectively.
In addition to continuous monitoring, project-based
research is also required. These “ad hoc queries” can hap‑
pen any time and may occur in response to management
questions, requests for information for health authorities,
preparation for meetings and inspections, or other factors.
Performing ad hoc research projects and topic-specific
investigations on request allows regulatory teams to address
specific questions using the sources of information to which
they have access.
Communication Processes. As you continually observe the
regulatory landscape, you will receive numerous alerts, only
some of which will apply to your organization. Establishing
an efficient triaging process to review and filter this incoming
information is crucial. By quickly sorting relevant informa‑
tion from irrelevant information, you allow your team to
focus on the most impactful updates, reducing information
overload and enhancing the overall efficiency of your RI pro‑
gram. The triaging process your team follows will be specific
to the people and tools you employ.
As you detect new relevant information, you need to
communicate it to your stakeholders. These communications
Figure 1-5. Processes Within Each Component of an RI Program
Observe
• Define regions, top-
ics, and therapeutic
areas of interest
• Define primary and
secondary sources
of intelligence
• Continuously
monitor &scan
intelligence sources
• Perform ad hoc
research projects
&topic-specific
investigations on
request
• Triage new informa-
tion for relevance
• Communicate rel-
evant information
via writing and oral
presentations
• Maintain and use
distribution lists
• Update internal
databases and
knowledge manage-
ment (KM) systems
• Assess impact to
quality, compliance,
and operational
programs
• Assess impact to
product develop-
ment strategies,
labels/target prod-
uct profiles (TPPs)
• Assess impact to
global filing plans
• Assess impact to
policy positions
• Review and com-
ment development
• Prepare for meet-
ings, inspections,
and due diligence
• Implement quality,
compliance, and
operational changes
• Create/update
strategies, labels/
TPPs for medical
products
• Create/update
global filing plans
• Create/update
policy positions
• Report &submit
to agencies &
associations
• Conduct meetings,
audits, health
authority (HA)
inspections, &due
diligence
• Respond to
requests for
information
Communicate Evaluate Act
Source: Chris Whalley
7 Regulatory Affairs Professionals Society
For each agency or organization you are following, here
are some examples of the types of information RI programs
can involve:
• Agency regulations and policies
• Guidance for industry
• Regional and international standards
• Product approvals, safety changes, and assessment
reports
• Meeting announcements and
• Publications by agency authors (interviews, conference
presentations, journal publications, etc.)
Once the areas of interest are defined, establishing primary
and secondary sources of intelligence is essential for gather‑
ing comprehensive and reliable information. Primary sources,
such as agency websites, public meetings and workshops,
agency-authored publications, and internal team experi‑
ences, provide firsthand insights and data. Secondary sources,
including media reports, commercial database providers,
trade associations, and consortia reports, among others, offer
valuable context and background information. For most orga‑
nizations, it is unlikely that a single source of information will
provide all the information you need. By leveraging multiple
sources, organizations can build a robust foundation for their
RI program.
Once primary and secondary sources of information are
established, continuously monitoring and scanning them is
vital for staying current with the latest developments and
trends. This proactive approach involves regularly reviewing
new and revised information to ensure accuracy and consis‑
tency. The frequency and depth of monitoring will depend
on the size and skills of your team, as well as the technology
used. By continuously monitoring your sources, organizations
can quickly identify emerging opportunities, potential threats,
and shifts in the regulatory landscape, enabling them to
respond swiftly and effectively.
In addition to continuous monitoring, project-based
research is also required. These “ad hoc queries” can hap‑
pen any time and may occur in response to management
questions, requests for information for health authorities,
preparation for meetings and inspections, or other factors.
Performing ad hoc research projects and topic-specific
investigations on request allows regulatory teams to address
specific questions using the sources of information to which
they have access.
Communication Processes. As you continually observe the
regulatory landscape, you will receive numerous alerts, only
some of which will apply to your organization. Establishing
an efficient triaging process to review and filter this incoming
information is crucial. By quickly sorting relevant informa‑
tion from irrelevant information, you allow your team to
focus on the most impactful updates, reducing information
overload and enhancing the overall efficiency of your RI pro‑
gram. The triaging process your team follows will be specific
to the people and tools you employ.
As you detect new relevant information, you need to
communicate it to your stakeholders. These communications
Figure 1-5. Processes Within Each Component of an RI Program
Observe
• Define regions, top-
ics, and therapeutic
areas of interest
• Define primary and
secondary sources
of intelligence
• Continuously
monitor &scan
intelligence sources
• Perform ad hoc
research projects
&topic-specific
investigations on
request
• Triage new informa-
tion for relevance
• Communicate rel-
evant information
via writing and oral
presentations
• Maintain and use
distribution lists
• Update internal
databases and
knowledge manage-
ment (KM) systems
• Assess impact to
quality, compliance,
and operational
programs
• Assess impact to
product develop-
ment strategies,
labels/target prod-
uct profiles (TPPs)
• Assess impact to
global filing plans
• Assess impact to
policy positions
• Review and com-
ment development
• Prepare for meet-
ings, inspections,
and due diligence
• Implement quality,
compliance, and
operational changes
• Create/update
strategies, labels/
TPPs for medical
products
• Create/update
global filing plans
• Create/update
policy positions
• Report &submit
to agencies &
associations
• Conduct meetings,
audits, health
authority (HA)
inspections, &due
diligence
• Respond to
requests for
information
Communicate Evaluate Act
Source: Chris Whalley