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6 The Basic Regulatory
Intelligence Toolbox
By Daanish Ashraf, PharmD and Mary Nteris, PhD, GAICD
Introduction
Similar to the preparation needed to assemble a
new piece of furniture, the regulatory intelligence
(RI) professional needs to determine which tools
are required to complete a project. Conducting
regulatory intelligence requires knowledge of
available tools, so when presented with a question,
strategy, research, or due diligence request, the RI
professional will be aware of potential resources
available to assist in answering these requests.
The tools in a RI professional’s toolbox will
depend on the company’s resources and leader-
ship’s view of the value and competitive edge RI
provides. This chapter serves as an introduction
to free and subscription-based tools, as this
typically is the dividing line between small and
large company resources. A large company can
use a variety of different RI tools, both free and
subscription-based, while smaller companies
tend to rely largely on free tools. However, the
RI process and goal are largely the same for any
size company: to be able to track and analyze the
regulatory environment and prepare for future
obstacles as the company progresses through
drug development, aiming for a speedy approval.
In general, RI professionals should be adept at
using free RI tools, as those can be used regardless
of the size of the company they support. However,
it is important to note that having the proper tools
can save time, and therefore, money.
Sources of Regulatory Information
Numerous sources of regulatory information are
available, each with a variety of uses. In addition,
multiple sources might be required to answer
a question, develop a strategy, or support the
position. Often, the questions are simple and
do not require much research others may take
hours of data mining to locate the answer. The
most utilized sources of regulatory information
are material provided by the governments and
regulatory agencies in the countries of interest.
These include the following:
• Country regulations laws and directives
• Regulatory agency guidance documents
• Documents, recordings, and transcripts
from meetings and workshops held by
regulatory agencies
• Regulatory/health authority websites
• Publications from health agencies
• Regulatory precedent databases hosted
by regulatory agencies (e.g., https://www.
accessdata.fda.gov/scripts/cder/daf/)
These resources are usually free to access and
should be considered as the foundation for every
RI professional’s toolbox. See Chapter 10, Public
Sources of Regulatory Precedent, Chapter 12,
Regulations and Guidances, and Chapter 13,
White Papers for more detailed information on
these types of resources.
However, regulations and guidance docu-
ments tell only half the story the sources listed
above provide black and white facts, while most
of the regulatory information sought is gray. In
addition, locating information on a regulator’s
website may be difficult without the help of
third-party databases. This is where subscrip-
tion-based tools become useful subscription
regulatory information resources include:
CHAPTER
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41
6 The Basic Regulatory
Intelligence Toolbox
By Daanish Ashraf, PharmD and Mary Nteris, PhD, GAICD
Introduction
Similar to the preparation needed to assemble a
new piece of furniture, the regulatory intelligence
(RI) professional needs to determine which tools
are required to complete a project. Conducting
regulatory intelligence requires knowledge of
available tools, so when presented with a question,
strategy, research, or due diligence request, the RI
professional will be aware of potential resources
available to assist in answering these requests.
The tools in a RI professional’s toolbox will
depend on the company’s resources and leader-
ship’s view of the value and competitive edge RI
provides. This chapter serves as an introduction
to free and subscription-based tools, as this
typically is the dividing line between small and
large company resources. A large company can
use a variety of different RI tools, both free and
subscription-based, while smaller companies
tend to rely largely on free tools. However, the
RI process and goal are largely the same for any
size company: to be able to track and analyze the
regulatory environment and prepare for future
obstacles as the company progresses through
drug development, aiming for a speedy approval.
In general, RI professionals should be adept at
using free RI tools, as those can be used regardless
of the size of the company they support. However,
it is important to note that having the proper tools
can save time, and therefore, money.
Sources of Regulatory Information
Numerous sources of regulatory information are
available, each with a variety of uses. In addition,
multiple sources might be required to answer
a question, develop a strategy, or support the
position. Often, the questions are simple and
do not require much research others may take
hours of data mining to locate the answer. The
most utilized sources of regulatory information
are material provided by the governments and
regulatory agencies in the countries of interest.
These include the following:
• Country regulations laws and directives
• Regulatory agency guidance documents
• Documents, recordings, and transcripts
from meetings and workshops held by
regulatory agencies
• Regulatory/health authority websites
• Publications from health agencies
• Regulatory precedent databases hosted
by regulatory agencies (e.g., https://www.
accessdata.fda.gov/scripts/cder/daf/)
These resources are usually free to access and
should be considered as the foundation for every
RI professional’s toolbox. See Chapter 10, Public
Sources of Regulatory Precedent, Chapter 12,
Regulations and Guidances, and Chapter 13,
White Papers for more detailed information on
these types of resources.
However, regulations and guidance docu-
ments tell only half the story the sources listed
above provide black and white facts, while most
of the regulatory information sought is gray. In
addition, locating information on a regulator’s
website may be difficult without the help of
third-party databases. This is where subscrip-
tion-based tools become useful subscription
regulatory information resources include:
CHAPTER