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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
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local level, with local regulatory staff responsible
for regulatory agency interactions.
Other changes, such as safety-related updates
following unexpected serious adverse events and
signals detected through postmarketing surveil-
lance, often are accompanied by tight regulatory
timelines for notifying the regulatory agency and
updating product information documentation to
ensure new risks are communicated promptly to
patients and healthcare professionals. Although it
is not possible to plan specific regulatory interac-
tions in advance, global planning for such events is
vital to enable rapid implementation if these occur.
A multidisciplinary team including experts in reg-
ulatory and safety, compliance, risk management,
communications and marketing should document
procedures and ensure all key staff (and backups)
are trained and ready to implement the plan,
if necessary. A local plan should be developed,
consistent with each region and country, that links
into the global plan.
Knowledge Management
Knowledge management is one of the most
significant regulatory challenges. Regulatory
expertise often is comprised of knowledge of
what is written in regulation, knowledge of
precedence and actual personal experience and
a set of relationships with the relevant authority
that help the regulatory professional collectively
provide advice on what is ‘required’ and what is
‘expected’ to deliver a positive outcome.
Experience Capture
Properly captured knowledge and centralized
information sources yield process efficiencies.
Actions taken by companies for proper knowl-
edge codification and dissemination include:
• creating an “expert tracker” database for
knowledge residing with the organiza-
tion’s employees and attempting to cen-
tralize and disseminate that information
• disseminating information through
multi-level training at different career
stages for regulatory and affiliated
personnel
• creating customized reports interpreting
regulations and ensuring the regulatory
function is the ultimate authority on all
regulatory compliance aspects
• tracking regulatory key performance
indicators with a balance of lagging
indicators (e.g., issues generated after
product launch) and leading indicators
(e.g., revenue at risk from potential
regulation changes)
Regulatory functions within organizations,
especially those with global programs, should not
be merely reactive and tactical, but more proac-
tive and aligned with the organization’s global
product strategy to ensure minimal regulatory
compliance challenges and timely mitigation of
nonconformance risks.
Regulation Database
Companies need to have reliable, current
knowledge databases to track technical and legal
requirements for each country in which they
intend to submit regulatory dossiers. Commercial
databases are available, and/or companies can
utilize staff to provide local intelligence. Local
direct intelligence advantages include supple-
menting local published guidance with practical
insights and experience of what actually was
required in addition to what was published. If
using a commercial database, the information’s
currency should be confirmed, as regulations
change frequently, especially in countries with
evolving regulatory frameworks.
Knowing the Regulatory Authority
Organizations need to know not only the written
regulatory requirements, they also should have a
good understanding of unwritten requirements
and the personal preferences of any agency
reviewers who may review their dossiers.
If possible, regulatory personnel should be
encouraged or advised to interact with the regu-
lators during new product development, although
it is not possible or efficient to meet with all
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
local level, with local regulatory staff responsible
for regulatory agency interactions.
Other changes, such as safety-related updates
following unexpected serious adverse events and
signals detected through postmarketing surveil-
lance, often are accompanied by tight regulatory
timelines for notifying the regulatory agency and
updating product information documentation to
ensure new risks are communicated promptly to
patients and healthcare professionals. Although it
is not possible to plan specific regulatory interac-
tions in advance, global planning for such events is
vital to enable rapid implementation if these occur.
A multidisciplinary team including experts in reg-
ulatory and safety, compliance, risk management,
communications and marketing should document
procedures and ensure all key staff (and backups)
are trained and ready to implement the plan,
if necessary. A local plan should be developed,
consistent with each region and country, that links
into the global plan.
Knowledge Management
Knowledge management is one of the most
significant regulatory challenges. Regulatory
expertise often is comprised of knowledge of
what is written in regulation, knowledge of
precedence and actual personal experience and
a set of relationships with the relevant authority
that help the regulatory professional collectively
provide advice on what is ‘required’ and what is
‘expected’ to deliver a positive outcome.
Experience Capture
Properly captured knowledge and centralized
information sources yield process efficiencies.
Actions taken by companies for proper knowl-
edge codification and dissemination include:
• creating an “expert tracker” database for
knowledge residing with the organiza-
tion’s employees and attempting to cen-
tralize and disseminate that information
• disseminating information through
multi-level training at different career
stages for regulatory and affiliated
personnel
• creating customized reports interpreting
regulations and ensuring the regulatory
function is the ultimate authority on all
regulatory compliance aspects
• tracking regulatory key performance
indicators with a balance of lagging
indicators (e.g., issues generated after
product launch) and leading indicators
(e.g., revenue at risk from potential
regulation changes)
Regulatory functions within organizations,
especially those with global programs, should not
be merely reactive and tactical, but more proac-
tive and aligned with the organization’s global
product strategy to ensure minimal regulatory
compliance challenges and timely mitigation of
nonconformance risks.
Regulation Database
Companies need to have reliable, current
knowledge databases to track technical and legal
requirements for each country in which they
intend to submit regulatory dossiers. Commercial
databases are available, and/or companies can
utilize staff to provide local intelligence. Local
direct intelligence advantages include supple-
menting local published guidance with practical
insights and experience of what actually was
required in addition to what was published. If
using a commercial database, the information’s
currency should be confirmed, as regulations
change frequently, especially in countries with
evolving regulatory frameworks.
Knowing the Regulatory Authority
Organizations need to know not only the written
regulatory requirements, they also should have a
good understanding of unwritten requirements
and the personal preferences of any agency
reviewers who may review their dossiers.
If possible, regulatory personnel should be
encouraged or advised to interact with the regu-
lators during new product development, although
it is not possible or efficient to meet with all