34
Chapter 5: How to Set Up an RI Department
basis to meet the demands of an evolving regu-
latory environment.
A significant task of any RI function or
department is to develop and maintain good
stakeholder engagement as shown in Figure 5-3.
The internal regulatory staff are the primary
customers of an RI department.
• Engagement and communication are
essential, and methods of receiving
intelligence may differ based on
personal preferences.
• Internal customers should know how to
contact the RI department and the level
of support they can expect to receive.
• The RI department should conduct
training and raise awareness for any
internal processes or tools to avoid
duplication of effort in gathering RI.
Other internal functions, such as R&D,
manufacturing, management, etc., also can be
customers and subject matter experts within an
RI department.
• Subject matter experts should
understand why their contributions to
impact analysis are valuable
• The RI department should advise
subject matter experts on how to
provide quality insights.
The external, broader regulatory affairs commu-
nity will be a good source for information on ini-
tiatives not yet published and common practices
or tools that can facilitate daily RI activities.
Core Investment
Regardless of company size, organizing an RI
department is possible, even on a limited budget.
The minimum requirements are described in
Figure 5-4.
Should the RI Department be
separate from other regulatory
groups?
The short answer is not necessarily.
• Different companies may have different
organizational structures and needs,
depending on the company size (e.g.,
different needs and capabilities) and
overall structure (e.g., human drugs and
Figure 5-2. Steps in Setting Up an RI
Department 1
2
3
4
5
Map internal
‘customer’ needs
Connect with subject
matter experts
Roles and skills
inventory
Identify relevant
sources and tools
Set up RI System
and workflow
Figure 5-3. RI Department Stakeholder
Engagement
Internal regulatory
community
RI Department
External regulatory
community
Other internal
functions
Chapter 5: How to Set Up an RI Department
basis to meet the demands of an evolving regu-
latory environment.
A significant task of any RI function or
department is to develop and maintain good
stakeholder engagement as shown in Figure 5-3.
The internal regulatory staff are the primary
customers of an RI department.
• Engagement and communication are
essential, and methods of receiving
intelligence may differ based on
personal preferences.
• Internal customers should know how to
contact the RI department and the level
of support they can expect to receive.
• The RI department should conduct
training and raise awareness for any
internal processes or tools to avoid
duplication of effort in gathering RI.
Other internal functions, such as R&D,
manufacturing, management, etc., also can be
customers and subject matter experts within an
RI department.
• Subject matter experts should
understand why their contributions to
impact analysis are valuable
• The RI department should advise
subject matter experts on how to
provide quality insights.
The external, broader regulatory affairs commu-
nity will be a good source for information on ini-
tiatives not yet published and common practices
or tools that can facilitate daily RI activities.
Core Investment
Regardless of company size, organizing an RI
department is possible, even on a limited budget.
The minimum requirements are described in
Figure 5-4.
Should the RI Department be
separate from other regulatory
groups?
The short answer is not necessarily.
• Different companies may have different
organizational structures and needs,
depending on the company size (e.g.,
different needs and capabilities) and
overall structure (e.g., human drugs and
Figure 5-2. Steps in Setting Up an RI
Department 1
2
3
4
5
Map internal
‘customer’ needs
Connect with subject
matter experts
Roles and skills
inventory
Identify relevant
sources and tools
Set up RI System
and workflow
Figure 5-3. RI Department Stakeholder
Engagement
Internal regulatory
community
RI Department
External regulatory
community
Other internal
functions