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5 How to Set Up an RI Department
By Céline Rodier Seguy, PharmD, DES
Why would a company have an RI
Department?
The need for a dedicated RI function within
companies is increasing because:
• The pharmaceutical and medical device
industries are heavily regulated and
becoming more complex, requiring
dedicated staff to maintain surveillance
on regulatory changes and their impact
on the company.
• Companies must comply with the ever-
changing regulatory requirements in all
countries in which they operate.
A broad range of RI-related activities fall within
the RI department remit, as shown in Figure 5-1.
First Things First
No one is expected to be an expert on all the
regulations on a global level, but it is important
to consider the RI deliverables needed by the
organization in terms of scope (countries, topics),
output, and communication path.
To set up an RI department, it is essen-
tial to map the different internal ‘customers’ of
the department (e.g., regulatory affairs, R&D,
marketing, corporate) to better understand their
goals, how RI can help achieve these goals, and
how they use RI.
Connecting with internal subject matter
experts is the key to supporting further reg-
ulatory activities’ impact analysis. The person
setting up the RI department will have to map
RI activities, roles, and responsibilities. Therefore,
drawing up a skills inventory of current regula-
tory staff can provide an understanding of the
strengths and gaps required to fulfill the mission.
These preliminary steps should help identify
relevant resources (people and tools) to ensure an
appropriate workflow and system.
The steps described above and shown in
Figure 5-2 should be reassessed on a regular
To rapidly identify and
communicate significant changes
in the regulatory environment to
key internal stakeholders
To conduct and deliver unique and
insightful analyses that facilitate
strategic decision-making
To serve as internal regulatory
consultants and respond to
ad-hoc intelligence requests
To facilitate access to high-value
and frequently referenced
regulatory intelligence sources
Figure 5-1. RI Department Activities
CHAPTER
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5 How to Set Up an RI Department
By Céline Rodier Seguy, PharmD, DES
Why would a company have an RI
Department?
The need for a dedicated RI function within
companies is increasing because:
• The pharmaceutical and medical device
industries are heavily regulated and
becoming more complex, requiring
dedicated staff to maintain surveillance
on regulatory changes and their impact
on the company.
• Companies must comply with the ever-
changing regulatory requirements in all
countries in which they operate.
A broad range of RI-related activities fall within
the RI department remit, as shown in Figure 5-1.
First Things First
No one is expected to be an expert on all the
regulations on a global level, but it is important
to consider the RI deliverables needed by the
organization in terms of scope (countries, topics),
output, and communication path.
To set up an RI department, it is essen-
tial to map the different internal ‘customers’ of
the department (e.g., regulatory affairs, R&D,
marketing, corporate) to better understand their
goals, how RI can help achieve these goals, and
how they use RI.
Connecting with internal subject matter
experts is the key to supporting further reg-
ulatory activities’ impact analysis. The person
setting up the RI department will have to map
RI activities, roles, and responsibilities. Therefore,
drawing up a skills inventory of current regula-
tory staff can provide an understanding of the
strengths and gaps required to fulfill the mission.
These preliminary steps should help identify
relevant resources (people and tools) to ensure an
appropriate workflow and system.
The steps described above and shown in
Figure 5-2 should be reassessed on a regular
To rapidly identify and
communicate significant changes
in the regulatory environment to
key internal stakeholders
To conduct and deliver unique and
insightful analyses that facilitate
strategic decision-making
To serve as internal regulatory
consultants and respond to
ad-hoc intelligence requests
To facilitate access to high-value
and frequently referenced
regulatory intelligence sources
Figure 5-1. RI Department Activities
CHAPTER