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Regulatory Intelligence 101, Third Edition
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○ How much of the RI work will be
outsourced, and how much of it will
be done in house?
• Tools:
○ What tools will be purchased for
the function (databases, websites,
consultants, etc.)?
▪ A five-year plan can be created,
outlining what tools will be
purchased and what output
will be expected in each of the
first four years, and after full
implementation in the fifth year,
including how performance will
be measured.
▪ Tools, especially those critical to
making the RI professional’s life
easier, can be expensive. It often
is necessary to demonstrate
the value of the tool by time
saved (a vendor can often
provide this information), which
typically is significant (20–80+
hours saved). When the
workload increases, and the RI
department is asked to do more
work with the same number of
people, tools are essential. (the
individual justification can vary
but should be based on time and
money saved). If a department
starts with only free tools,
management should be made
aware that productivity might
be lower, as more manual work
will be required.
▪ To which journals should the
company subscribe, and will
they be archived electronically?
• Activities:
○ What will be monitored? (See
Chapter 7 Monitoring and
Surveillance)
○ How will new information be
evaluated against prior information?
○ How will new information be
integrated into current processes?
○ How will new regulations, forms, or
guidance documents be distributed?
○ What activities can be outsourced,
considering confidentiality issues,
and what knowledge of portfolio
and internal priorities is necessary to
perform an accurate impact analysis?
○ What are the expected deliverables?
▪ How will work be
communicated to stakeholders?
▪ How will work be stored and
managed?
▪ How will job function and
output be measured? (See
Chapter 21 RI Metrics)
• Budget:
○ What is the annual budget? This
should include:
▪ Basic costs
▪ People, including external
resources such as contractors or
consultants
▪ Tools
▪ Infrastructure (computers,
intranet, software, etc.)
○ Annual vs. onetime costs for
subscription and consulting fees
and tools
Once the RI Department is set up, its return on
investment (ROI) should be demonstrated by
showing how RI has:
• Reduced time to market
• Increased compliance
• Reduced costs of development
• Reduced or abolished costs of
noncompliance (financial, staff,
operational, and regulatory)
Small Versus Large Companies’
Organization
Small companies with one person conducting
RI part-time, and large companies with dedi-
cated RI departments of 3–15 all have similar-
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
○ How much of the RI work will be
outsourced, and how much of it will
be done in house?
• Tools:
○ What tools will be purchased for
the function (databases, websites,
consultants, etc.)?
▪ A five-year plan can be created,
outlining what tools will be
purchased and what output
will be expected in each of the
first four years, and after full
implementation in the fifth year,
including how performance will
be measured.
▪ Tools, especially those critical to
making the RI professional’s life
easier, can be expensive. It often
is necessary to demonstrate
the value of the tool by time
saved (a vendor can often
provide this information), which
typically is significant (20–80+
hours saved). When the
workload increases, and the RI
department is asked to do more
work with the same number of
people, tools are essential. (the
individual justification can vary
but should be based on time and
money saved). If a department
starts with only free tools,
management should be made
aware that productivity might
be lower, as more manual work
will be required.
▪ To which journals should the
company subscribe, and will
they be archived electronically?
• Activities:
○ What will be monitored? (See
Chapter 7 Monitoring and
Surveillance)
○ How will new information be
evaluated against prior information?
○ How will new information be
integrated into current processes?
○ How will new regulations, forms, or
guidance documents be distributed?
○ What activities can be outsourced,
considering confidentiality issues,
and what knowledge of portfolio
and internal priorities is necessary to
perform an accurate impact analysis?
○ What are the expected deliverables?
▪ How will work be
communicated to stakeholders?
▪ How will work be stored and
managed?
▪ How will job function and
output be measured? (See
Chapter 21 RI Metrics)
• Budget:
○ What is the annual budget? This
should include:
▪ Basic costs
▪ People, including external
resources such as contractors or
consultants
▪ Tools
▪ Infrastructure (computers,
intranet, software, etc.)
○ Annual vs. onetime costs for
subscription and consulting fees
and tools
Once the RI Department is set up, its return on
investment (ROI) should be demonstrated by
showing how RI has:
• Reduced time to market
• Increased compliance
• Reduced costs of development
• Reduced or abolished costs of
noncompliance (financial, staff,
operational, and regulatory)
Small Versus Large Companies’
Organization
Small companies with one person conducting
RI part-time, and large companies with dedi-
cated RI departments of 3–15 all have similar-