Global Medical Device Regulatory Strategy
47 Regulatory Affairs Professionals Society
4
Components of Regulatory
Strategy – The Basics
Melissa Walker, MS, RAC-US, FRAPS
Introduction
A strategy is defined as a careful plan or method for
achieving a particular goal usually over a long period
of time. The end goal of a regulatory strategy is to
obtain safe and effective products for patients who
need them for as long as they are needed. To do that as
quickly and efficiently as possible, manufacturers must
consider a range of factors. A global regulatory strategy
is needed for any new product. Where does a regula-
tory professional start? As the King said to the White
Rabbit in Alice in Wonderland, “Begin at the begin-
ning and go on till you come to the end: then stop.”
The beginning stage of a global regulatory is the
patient need and the company’s plan to meet that
need. The end comes when the product is no longer
used or on the market. During the product’s entire
lifecycle, the regulatory strategy must be updated con-
stantly to adjust to shifting requirements of patients,
physicians, and regulatory agencies. Why start with
the product plans? These are the boundaries for the
strategy. The countries selected, resources available,
and market timing will drive the final strategy.
Gather Information
The regulatory professional should keep in mind
that information gathering will be helpful for both
the Global Regulatory Strategy (GRS) and the
regulatory plan. Think of the strategy as the overall
approach to getting the product to market. The GRS
should include a top-level summary of what needs
to be accomplished to get the product to health-
care professionals and patients. The regulatory plan
should be much more detailed, offering direction
and requirements to the project team. The differ-
ence between these two documents is detailed in the
Communicating the Strategy section of this chapter.
Before gathering information, the regulatory
professional should make a list of the elements that
should be included in the GRS and the regulatory
plan. The circumstances surrounding individuals’
projects can differ significantly. The GRS contents
should reflect the project’s nature and should guide
both the research and analysis efforts. Other stake-
holders’ questions, priorities, timing, and outcomes
should be incorporated in the research efforts. When
assembling the strategy, it is highly likely that some
elements will not meet the project team’s ideal out-
come. These points will need to be defended when the
strategy is reviewed. The regulatory professional can
minimize the length of the debate by supporting the
variation from the ideal with effective data.
The GRS elements and necessary information
should be identified, including a brief statement on
expectations from the project plan. The team must
consider the type of research methodology that will
best fit each element. Some elements will require
an exploration of something (qualitative research),
while others may start with a hypothesis (quantitative
research). Some elements may require both. At this
initial stage, the regulatory professional should do
his or her best to identify the type of research and
47 Regulatory Affairs Professionals Society
4
Components of Regulatory
Strategy – The Basics
Melissa Walker, MS, RAC-US, FRAPS
Introduction
A strategy is defined as a careful plan or method for
achieving a particular goal usually over a long period
of time. The end goal of a regulatory strategy is to
obtain safe and effective products for patients who
need them for as long as they are needed. To do that as
quickly and efficiently as possible, manufacturers must
consider a range of factors. A global regulatory strategy
is needed for any new product. Where does a regula-
tory professional start? As the King said to the White
Rabbit in Alice in Wonderland, “Begin at the begin-
ning and go on till you come to the end: then stop.”
The beginning stage of a global regulatory is the
patient need and the company’s plan to meet that
need. The end comes when the product is no longer
used or on the market. During the product’s entire
lifecycle, the regulatory strategy must be updated con-
stantly to adjust to shifting requirements of patients,
physicians, and regulatory agencies. Why start with
the product plans? These are the boundaries for the
strategy. The countries selected, resources available,
and market timing will drive the final strategy.
Gather Information
The regulatory professional should keep in mind
that information gathering will be helpful for both
the Global Regulatory Strategy (GRS) and the
regulatory plan. Think of the strategy as the overall
approach to getting the product to market. The GRS
should include a top-level summary of what needs
to be accomplished to get the product to health-
care professionals and patients. The regulatory plan
should be much more detailed, offering direction
and requirements to the project team. The differ-
ence between these two documents is detailed in the
Communicating the Strategy section of this chapter.
Before gathering information, the regulatory
professional should make a list of the elements that
should be included in the GRS and the regulatory
plan. The circumstances surrounding individuals’
projects can differ significantly. The GRS contents
should reflect the project’s nature and should guide
both the research and analysis efforts. Other stake-
holders’ questions, priorities, timing, and outcomes
should be incorporated in the research efforts. When
assembling the strategy, it is highly likely that some
elements will not meet the project team’s ideal out-
come. These points will need to be defended when the
strategy is reviewed. The regulatory professional can
minimize the length of the debate by supporting the
variation from the ideal with effective data.
The GRS elements and necessary information
should be identified, including a brief statement on
expectations from the project plan. The team must
consider the type of research methodology that will
best fit each element. Some elements will require
an exploration of something (qualitative research),
while others may start with a hypothesis (quantitative
research). Some elements may require both. At this
initial stage, the regulatory professional should do
his or her best to identify the type of research and