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
1
1 The Five Ws and H of Regulatory
Intelligence
By Darin Oppenheimer, DRSc, RAC, PMP, George Cusatis, MS, RAC,
and Suraj Ramachandran, MS, RAC
“An organization’s ability to learn and
translate that learning into action rapidly is
the ultimate competitive advantage.” Jack
Welch, former CEO of General Electric1
Often, the regulatory intelligence (RI) profes-
sional feels like an investigative journalist for the
organization for which they work. If not writing
an article for a newsletter, they might be author-
ing a summary of a newly passed regulation,
guidance document, current trend, or perhaps
pulling together the answer to a research ques-
tion. All of these principles rely on the investiga-
tive approach that can be thought of as the five
Ws and the H:
• What?
• Why?
• Where?
• When?
• Who?
• How?
Since RI professionals operate by the above
deduction principles, this chapter covers RI
basics based on answering the core questions of
the five Ws and the H.
What?
RI has been performed in some way, shape, or
form since regulatory was formally recognized
as a profession in the US in the 1960s. At that
time, RI was considered part of a regulatory
professional’s job and was limited to surveil-
lance of newly issued regulations and guidance
documents. RI presentations started appearing
at formal professional meetings around the year
1964. Acceptance of RI as a separate function
in regulatory has gained momentum since that
time, as the need and benefits have been realized
by drug and device companies alike. It is no lon-
ger enough to just provide ‘regulatory guidance’
the RI professional’s role has become that of a
regulatory science-driven strategist.
Rapid expansion of the healthcare sector has
thrust companies under mounting pressure to
deliver vitally innovative medical products. Regu-
latory affairs has undergone a revolution in order
to tackle the challenges of the drug and device
development process. The demands of this metic-
ulous process forces organizations to strategize
well in advance and anticipate potential obstacles
that may interfere with expedition of the product
to market. The need for strategy follows a gap in
knowledge critical to ensuring compliance with
federal regulations and distinction from competi-
tion. To convert a colossal amount of information
to digestible, impactful deliverables is a strenuous
effort unless performed efficiently. There are a
plethora of circumstances where actionable intel-
ligence may serve as a boon toward innovative
product development. The performance of regu-
latory intelligence personnel is inherently linked
with their ability to keep pace with a rapidly
changing landscape. Appropriate applications of
available resources for product development will
minimize target timeline deviations, improving
the probability for successful regulatory approval.
Efficient utilization of regulatory intelligence
unlocks new opportunities by allowing an
CHAPTER
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
1
1 The Five Ws and H of Regulatory
Intelligence
By Darin Oppenheimer, DRSc, RAC, PMP, George Cusatis, MS, RAC,
and Suraj Ramachandran, MS, RAC
“An organization’s ability to learn and
translate that learning into action rapidly is
the ultimate competitive advantage.” Jack
Welch, former CEO of General Electric1
Often, the regulatory intelligence (RI) profes-
sional feels like an investigative journalist for the
organization for which they work. If not writing
an article for a newsletter, they might be author-
ing a summary of a newly passed regulation,
guidance document, current trend, or perhaps
pulling together the answer to a research ques-
tion. All of these principles rely on the investiga-
tive approach that can be thought of as the five
Ws and the H:
• What?
• Why?
• Where?
• When?
• Who?
• How?
Since RI professionals operate by the above
deduction principles, this chapter covers RI
basics based on answering the core questions of
the five Ws and the H.
What?
RI has been performed in some way, shape, or
form since regulatory was formally recognized
as a profession in the US in the 1960s. At that
time, RI was considered part of a regulatory
professional’s job and was limited to surveil-
lance of newly issued regulations and guidance
documents. RI presentations started appearing
at formal professional meetings around the year
1964. Acceptance of RI as a separate function
in regulatory has gained momentum since that
time, as the need and benefits have been realized
by drug and device companies alike. It is no lon-
ger enough to just provide ‘regulatory guidance’
the RI professional’s role has become that of a
regulatory science-driven strategist.
Rapid expansion of the healthcare sector has
thrust companies under mounting pressure to
deliver vitally innovative medical products. Regu-
latory affairs has undergone a revolution in order
to tackle the challenges of the drug and device
development process. The demands of this metic-
ulous process forces organizations to strategize
well in advance and anticipate potential obstacles
that may interfere with expedition of the product
to market. The need for strategy follows a gap in
knowledge critical to ensuring compliance with
federal regulations and distinction from competi-
tion. To convert a colossal amount of information
to digestible, impactful deliverables is a strenuous
effort unless performed efficiently. There are a
plethora of circumstances where actionable intel-
ligence may serve as a boon toward innovative
product development. The performance of regu-
latory intelligence personnel is inherently linked
with their ability to keep pace with a rapidly
changing landscape. Appropriate applications of
available resources for product development will
minimize target timeline deviations, improving
the probability for successful regulatory approval.
Efficient utilization of regulatory intelligence
unlocks new opportunities by allowing an
CHAPTER