Chapter 4: Components of Regulatory Strategy – The Basics
54 Regulatory Affairs Professionals Society
A change in practice, however, can come
very quickly, with no advance notice or warning.
Regulatory authorities have a clear view of the pres-
ence and cause of product problems. This knowledge
can affect many aspects of similar products’ reviews
and requirements, without prior signals to sponsors.
Anticipating these types of changes – identifying the
invisible regulatory risks – is an important aspect to
consider in both GSR generation and regulatory plan
execution.
This can be the most difficult element of a GRS.
Keeping current on environmental changes is a huge
challenge for the regulatory professional, who should
use his or her network of other regulatory profes-
sionals in addition to available public information.
Combining these resources provides the best support
for the strategy.
Resources
• What regulatory resources are needed to support
the GRS?
• What type of expertise is needed?
• Can the project be supported by external
resources?
• What in-country resources are available to sup-
port registrations there?
Creating and executing a GRS requires considerable
time and effort. Although the team often focuses on
what happens following the submission, creating and
organizing the submission is no small task. This is
particularly true when the product plan schedule calls
for simultaneous or overlapping submission dates. It
often is easier for stakeholders to understand the need
for an additional engineer than for more regulatory
staff. Thus, the GRS resource section is critical to
project success.
Many methods exist for estimating the resources
needed to execute the GRS successfully. Project
management software programs can be helpful, and a
spreadsheet program can be used to determine where
resources may be constrained. Requests for additional
resources will be scrutinized closely. The GRS should
make a solid case for additional support.
Regulatory staff often are spread over multiple
projects and responsibilities. Each project has its
own timeline and milestones. As a shared resource,
regulatory staff must balance their workload around
each team’s schedule. The team must carefully con-
sider this variable when developing the resource plan.
Project teams focus on their projects and make them
their first priorities. The should be allowed sufficient
time for submission preparation, review, and editing.
Even final submission preparations (e.g., electronic
format, multiple paper copies) take time and should
be included in the plan.
Some project aspects may require different areas
of expertise not available within the organization.
This applies to regulatory and other functions. For
example, if the project is the first to require a clinical
trial, study design, statistics, or US Investigational
Device Exemption, it may require submission
expertise. If the project incorporates a new software
program, regulatory expertise in this area may be
needed. It is necessary to determine whether this
resource should be a permanent staff addition or an
external resource. Adding a consultant will take time
to identify and familiarize the person or firm with
the project. This task also should be considered in the
resource analysis.
Assemble the Strategy
• What elements comprise the GRS versus the
regulatory plan?
• What types of analyses are needed?
• What if analysis results differ from the product
plan?
• What resources are needed to execute the strat-
egy successfully?
Various stakeholders’ interests will depend on the
project’s nature, as well as the regulatory research
results. At minimum, the GRS summary should
address the following:
• Brief device description and indication statement
• List of countries (in order of market preference)
• For each country
• Regulatory path
• Particular points of regulatory concern
• Clinical trial requirements
• Approximate preparation and review time
• Regulatory risk areas
• Regulatory areas to be monitored as the project
proceeds
• Required resources
The regulatory plan should detail the GRS topics
since it is the development team’s guideline. This
plan also will be the basis for regulatory project
management.
• Key milestones
• Design and testing requirements
• Clinical data requirements
• Relevant guidance documents and standards4,5
• Risk analysis elements
• Resources used for the plan (e.g., websites,
publications)
54 Regulatory Affairs Professionals Society
A change in practice, however, can come
very quickly, with no advance notice or warning.
Regulatory authorities have a clear view of the pres-
ence and cause of product problems. This knowledge
can affect many aspects of similar products’ reviews
and requirements, without prior signals to sponsors.
Anticipating these types of changes – identifying the
invisible regulatory risks – is an important aspect to
consider in both GSR generation and regulatory plan
execution.
This can be the most difficult element of a GRS.
Keeping current on environmental changes is a huge
challenge for the regulatory professional, who should
use his or her network of other regulatory profes-
sionals in addition to available public information.
Combining these resources provides the best support
for the strategy.
Resources
• What regulatory resources are needed to support
the GRS?
• What type of expertise is needed?
• Can the project be supported by external
resources?
• What in-country resources are available to sup-
port registrations there?
Creating and executing a GRS requires considerable
time and effort. Although the team often focuses on
what happens following the submission, creating and
organizing the submission is no small task. This is
particularly true when the product plan schedule calls
for simultaneous or overlapping submission dates. It
often is easier for stakeholders to understand the need
for an additional engineer than for more regulatory
staff. Thus, the GRS resource section is critical to
project success.
Many methods exist for estimating the resources
needed to execute the GRS successfully. Project
management software programs can be helpful, and a
spreadsheet program can be used to determine where
resources may be constrained. Requests for additional
resources will be scrutinized closely. The GRS should
make a solid case for additional support.
Regulatory staff often are spread over multiple
projects and responsibilities. Each project has its
own timeline and milestones. As a shared resource,
regulatory staff must balance their workload around
each team’s schedule. The team must carefully con-
sider this variable when developing the resource plan.
Project teams focus on their projects and make them
their first priorities. The should be allowed sufficient
time for submission preparation, review, and editing.
Even final submission preparations (e.g., electronic
format, multiple paper copies) take time and should
be included in the plan.
Some project aspects may require different areas
of expertise not available within the organization.
This applies to regulatory and other functions. For
example, if the project is the first to require a clinical
trial, study design, statistics, or US Investigational
Device Exemption, it may require submission
expertise. If the project incorporates a new software
program, regulatory expertise in this area may be
needed. It is necessary to determine whether this
resource should be a permanent staff addition or an
external resource. Adding a consultant will take time
to identify and familiarize the person or firm with
the project. This task also should be considered in the
resource analysis.
Assemble the Strategy
• What elements comprise the GRS versus the
regulatory plan?
• What types of analyses are needed?
• What if analysis results differ from the product
plan?
• What resources are needed to execute the strat-
egy successfully?
Various stakeholders’ interests will depend on the
project’s nature, as well as the regulatory research
results. At minimum, the GRS summary should
address the following:
• Brief device description and indication statement
• List of countries (in order of market preference)
• For each country
• Regulatory path
• Particular points of regulatory concern
• Clinical trial requirements
• Approximate preparation and review time
• Regulatory risk areas
• Regulatory areas to be monitored as the project
proceeds
• Required resources
The regulatory plan should detail the GRS topics
since it is the development team’s guideline. This
plan also will be the basis for regulatory project
management.
• Key milestones
• Design and testing requirements
• Clinical data requirements
• Relevant guidance documents and standards4,5
• Risk analysis elements
• Resources used for the plan (e.g., websites,
publications)