39
Regulatory Intelligence 101, Third Edition
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Table 5-1. Comparison of Small and Large Companies’ RI Departments
Small Company Large Company
RI Structure
• Needs to be creative and flexible.
• More dependent on colleagues (network) and
consultants.
• Needs to do more with less, due to limited resources
and tools.
• Is a part-time role there are more distractions while
performing RI function.
• Needs to learn information quickly, as development
programs are dynamic.
• Reactive: often performed only when a question is
asked, or a topic needs to be researched (such as how
to file a CTA in Canada, Australia, and the EU).
RI Structure
• Dedicated, experienced team to perform a wide range
of RI functions.
• Workload divided by therapeutic area and/or region
for each RI analyst.
• Well-honed processes, forms, and maintenance
procedures.
• RI performed daily, enabling the company to catch
issues affecting product development or approved
products immediately and to implement change.
• For some projects, ability to dig deeper and provide
in-depth RI coverage and analysis.
Advantages
• Can move quickly and
nimbly from topic to
topic, depending on
day-to-day needs.
• Agility in developing
strategies (from
searches to strategic
decision).
Disadvantages
• Fewer resources.
• May not have an
electronic system to
help archive or store
information.
• Due to time constraints,
the RI professional
cannot dig as deeply or
research as extensively
as preferred because
day-to-day maintenance
regulatory work also
needs to be completed.
• Little to no access to
paid tools/databases,
increasing the time
and labor required to
complete RI activities.
Advantages
• Multiple tools and
databases used to
perform, communicate,
and manage RI output
efficiently.
• Knowledge management
databases bought or
created to manage
the wide variety of
regulatory information.
• Intranet or SharePoint
portals for company-
wide information
sharing.
• Dedicated affiliates
to help conduct
surveillance and provide
relevant information.
Disadvantages
• Segmented work,
depending on company
organization.
Conclusion
When establishing a regulatory intelligence
(RI) department, it is essential to map internal
‘customers’ of the department and to under-
stand their goals, how RI can help achieve these
goals, and how RI is used. A proposal outlining
the features of the RI department, its value,
and expected impact on the company, and the
tools and budget needed should be presented
to management. Different companies may have
different organizational structures and needs,
but given the pace of regulatory change, it is
imperative for the company to hire a dedicated
staff for consistent RI activities. Depending
on the size of the RI department and expected
activities, outsourcing may be an option, at least
on an ad hoc basis. Regardless of the organiza-
tion put in place, the RI function will need to
have efficient knowledge management.
Reference
1. “Regulatory Intelligence: How to do it well?” TOPRA
Roundtable, 25 June 2019. Céline Rodier and Carolyn
Hynes.
Regulatory Intelligence 101, Third Edition
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Table 5-1. Comparison of Small and Large Companies’ RI Departments
Small Company Large Company
RI Structure
• Needs to be creative and flexible.
• More dependent on colleagues (network) and
consultants.
• Needs to do more with less, due to limited resources
and tools.
• Is a part-time role there are more distractions while
performing RI function.
• Needs to learn information quickly, as development
programs are dynamic.
• Reactive: often performed only when a question is
asked, or a topic needs to be researched (such as how
to file a CTA in Canada, Australia, and the EU).
RI Structure
• Dedicated, experienced team to perform a wide range
of RI functions.
• Workload divided by therapeutic area and/or region
for each RI analyst.
• Well-honed processes, forms, and maintenance
procedures.
• RI performed daily, enabling the company to catch
issues affecting product development or approved
products immediately and to implement change.
• For some projects, ability to dig deeper and provide
in-depth RI coverage and analysis.
Advantages
• Can move quickly and
nimbly from topic to
topic, depending on
day-to-day needs.
• Agility in developing
strategies (from
searches to strategic
decision).
Disadvantages
• Fewer resources.
• May not have an
electronic system to
help archive or store
information.
• Due to time constraints,
the RI professional
cannot dig as deeply or
research as extensively
as preferred because
day-to-day maintenance
regulatory work also
needs to be completed.
• Little to no access to
paid tools/databases,
increasing the time
and labor required to
complete RI activities.
Advantages
• Multiple tools and
databases used to
perform, communicate,
and manage RI output
efficiently.
• Knowledge management
databases bought or
created to manage
the wide variety of
regulatory information.
• Intranet or SharePoint
portals for company-
wide information
sharing.
• Dedicated affiliates
to help conduct
surveillance and provide
relevant information.
Disadvantages
• Segmented work,
depending on company
organization.
Conclusion
When establishing a regulatory intelligence
(RI) department, it is essential to map internal
‘customers’ of the department and to under-
stand their goals, how RI can help achieve these
goals, and how RI is used. A proposal outlining
the features of the RI department, its value,
and expected impact on the company, and the
tools and budget needed should be presented
to management. Different companies may have
different organizational structures and needs,
but given the pace of regulatory change, it is
imperative for the company to hire a dedicated
staff for consistent RI activities. Depending
on the size of the RI department and expected
activities, outsourcing may be an option, at least
on an ad hoc basis. Regardless of the organiza-
tion put in place, the RI function will need to
have efficient knowledge management.
Reference
1. “Regulatory Intelligence: How to do it well?” TOPRA
Roundtable, 25 June 2019. Céline Rodier and Carolyn
Hynes.