35
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
biologics companies may differ from a
medical device company).
○ In small companies, RI may
fall within the regulatory affairs
department remit.
○ In larger companies, RI may be part
of a global policy function.
• Given the pace of regulatory changes, it
is important to have staff dedicated to
RI activities, so the rest of the regulatory
staff is not overburdened.
• Regardless of the companies’
organizational structure, it is essential for
the RI department and other regulatory
affairs department staff to collaborate
on working towards a common goal.
RI staff often lead the effort in sharing
experience and best practices across the
regulatory affairs department.
Recommending an RI Department to
Management and Demonstrating its
Value
A proposal should be prepared that outlines
the features of the RI department, its value and
expected impact on the company, the required
tools, and the budget. Please see Chapter 21 for
a discussion on measures of success.
RI is often conducted informally within
a company, but its value is not always recog-
nized. Establishing a formal department can be
challenging, as it means formally recognizing the
need for RI work as well as creating a proposed
budget for resources (tools, people, and possibly
contractors or consultants). To help establish a
department, the RI professional should outline
the expected deliverables and hold informational
meetings with internal stakeholders. What intel-
ligence deliverables would make their life easier?
These benefits are shown in Figure 5-5.
Once management understands the needs
of internal stakeholders, a proposal for the RI
department can be drafted, including a discus-
sion of budgetary issues. The main factors to
consider when setting up an RI department are
shown in Figure 5-6 and include:
• Staff:
○ Who will perform the function
(will the position be part-time or
full-time)? It would be best to find a
person with excellent research skills
(this cannot be stressed enough).
○ What are the RI professional’s
job description and overall
responsibilities?
Figure 5-4. Minimum Requirements for an RI Department
A willing person with
good research,
communication, and
networking skills and an
understanding of the
regulatory environment
A Regulatory
Intelligence toolbox
including databases
and subscriptions
(see “Chapter 6: The
Basic Regulatory
Intelligence Toolbox”)
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
biologics companies may differ from a
medical device company).
○ In small companies, RI may
fall within the regulatory affairs
department remit.
○ In larger companies, RI may be part
of a global policy function.
• Given the pace of regulatory changes, it
is important to have staff dedicated to
RI activities, so the rest of the regulatory
staff is not overburdened.
• Regardless of the companies’
organizational structure, it is essential for
the RI department and other regulatory
affairs department staff to collaborate
on working towards a common goal.
RI staff often lead the effort in sharing
experience and best practices across the
regulatory affairs department.
Recommending an RI Department to
Management and Demonstrating its
Value
A proposal should be prepared that outlines
the features of the RI department, its value and
expected impact on the company, the required
tools, and the budget. Please see Chapter 21 for
a discussion on measures of success.
RI is often conducted informally within
a company, but its value is not always recog-
nized. Establishing a formal department can be
challenging, as it means formally recognizing the
need for RI work as well as creating a proposed
budget for resources (tools, people, and possibly
contractors or consultants). To help establish a
department, the RI professional should outline
the expected deliverables and hold informational
meetings with internal stakeholders. What intel-
ligence deliverables would make their life easier?
These benefits are shown in Figure 5-5.
Once management understands the needs
of internal stakeholders, a proposal for the RI
department can be drafted, including a discus-
sion of budgetary issues. The main factors to
consider when setting up an RI department are
shown in Figure 5-6 and include:
• Staff:
○ Who will perform the function
(will the position be part-time or
full-time)? It would be best to find a
person with excellent research skills
(this cannot be stressed enough).
○ What are the RI professional’s
job description and overall
responsibilities?
Figure 5-4. Minimum Requirements for an RI Department
A willing person with
good research,
communication, and
networking skills and an
understanding of the
regulatory environment
A Regulatory
Intelligence toolbox
including databases
and subscriptions
(see “Chapter 6: The
Basic Regulatory
Intelligence Toolbox”)