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Global Regulatory Strategy
By Chris Walker and Tina Soulis
15
Introduction
The ultimate goal of a regulatory strategy is to
enable patient access, and it is within this context
that a regulatory professional must provide a
regulatory strategy. A regulatory strategy can
be defined as a science-driven assessment of a
product’s development options, key consider-
ations and likely regulatory outcome. It should
span the earliest development stages through
further modifications planned postauthorization.
It should encompass key milestones and decision
points consider regulatory objectives, hurdles,
the regulatory landscape and precedents and
characterize risks to potential success in deliver-
ing a specific regulatory outcome. This regulatory
outcome, in turn, will have broader consideration
because it will link to the potential for patient
access, commercial acceptability and uptake and,
therefore, likely business outcomes.
A global regulatory strategy should combine
regulatory requirements and business objectives.
It often is defined by a global regulatory expert,
who must consult with a cross-functional team.
The cross-functional team should comprise
experts who: provide regional regulatory require-
ments and regulatory intelligence on expecta-
tions, precedents and competition correspond
with local regulatory authorities enable docu-
ment management and submission processes
and provide specific functional expertise such as
labeling, CMC, nonclinical and clinical. There
also are internal and external business consider-
ations that can drive a specific global regulatory
strategy’s development. Examples of consid-
erations that influence global strategy are the
organization’s financial situation or the product’s
intellectual property status. External examples
include the organization’s business partner or
investor community viewpoints.
Global regulatory organizations must
provide comprehensive development plan input
throughout the product’s lifecycle. This input
starts in the preclinical development phase and
continues through postmarketing. Functional
regulatory units provide input on the likely
acceptability of the planned evidence package
that will be generated for the regulator and
subsequent stakeholders, specific regulatory
requirements for product development, post-
marketing, regulatory submission management,
regulatory intelligence, product labeling and
advertising and promotion.
Interdisciplinary Factors and Alignment
A global regulatory strategy cannot be planned
in isolation from other factors contributing
to an innovative new product’s overall suc-
cess. The most successful new products use a
multi-pronged development program approach,
addressing business, scientific and regulatory out-
comes. The integrated multidisciplinary product
development concept is shown in Figure 15-1.
Business Strategy
Business outcomes are defined broadly as those
accomplishments driving business results, includ-
ing revenue, earnings, cash flow, return on capital
and valuation.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Global Regulatory Strategy
By Chris Walker and Tina Soulis
15
Introduction
The ultimate goal of a regulatory strategy is to
enable patient access, and it is within this context
that a regulatory professional must provide a
regulatory strategy. A regulatory strategy can
be defined as a science-driven assessment of a
product’s development options, key consider-
ations and likely regulatory outcome. It should
span the earliest development stages through
further modifications planned postauthorization.
It should encompass key milestones and decision
points consider regulatory objectives, hurdles,
the regulatory landscape and precedents and
characterize risks to potential success in deliver-
ing a specific regulatory outcome. This regulatory
outcome, in turn, will have broader consideration
because it will link to the potential for patient
access, commercial acceptability and uptake and,
therefore, likely business outcomes.
A global regulatory strategy should combine
regulatory requirements and business objectives.
It often is defined by a global regulatory expert,
who must consult with a cross-functional team.
The cross-functional team should comprise
experts who: provide regional regulatory require-
ments and regulatory intelligence on expecta-
tions, precedents and competition correspond
with local regulatory authorities enable docu-
ment management and submission processes
and provide specific functional expertise such as
labeling, CMC, nonclinical and clinical. There
also are internal and external business consider-
ations that can drive a specific global regulatory
strategy’s development. Examples of consid-
erations that influence global strategy are the
organization’s financial situation or the product’s
intellectual property status. External examples
include the organization’s business partner or
investor community viewpoints.
Global regulatory organizations must
provide comprehensive development plan input
throughout the product’s lifecycle. This input
starts in the preclinical development phase and
continues through postmarketing. Functional
regulatory units provide input on the likely
acceptability of the planned evidence package
that will be generated for the regulator and
subsequent stakeholders, specific regulatory
requirements for product development, post-
marketing, regulatory submission management,
regulatory intelligence, product labeling and
advertising and promotion.
Interdisciplinary Factors and Alignment
A global regulatory strategy cannot be planned
in isolation from other factors contributing
to an innovative new product’s overall suc-
cess. The most successful new products use a
multi-pronged development program approach,
addressing business, scientific and regulatory out-
comes. The integrated multidisciplinary product
development concept is shown in Figure 15-1.
Business Strategy
Business outcomes are defined broadly as those
accomplishments driving business results, includ-
ing revenue, earnings, cash flow, return on capital
and valuation.