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Chapter 5: How to Set Up an RI Department
ities and differences as illustrated in Table 5-1.
How each company addresses their needs varies
based on experience, deliverables, and budget.
However, the RI process remains the same
regardless of size.
Outsourcing
Depending on the size of the RI department
and expected activities, outsourcing may be
a good option, at least on an ad hoc basis.
Outsourcing can solve resource availability chal-
lenges, including lack of competency or lan-
guage skills to monitor the regulatory landscape.
Outsourcing basic and repetitive activities can
free up time for internal staff to work on more
value-added activities.
Knowledge Management
How to Manage and Store Data and Data
Requests
RI output must be managed, stored, and shared
to learn from experience and avoid duplication
of effort. For small companies, an intranet site
(such as SharePoint) is an effective way to man-
age and share data, including requests. Larger
companies can use an intranet site or dashboard
and databases (in-house, custom or off-the-
shelf) and more-efficient systems for managing
information requests, fulfilling requests, posting
hot topics, and distributing new regulations or
guidance documents.
Intranet/SharePoint Site
What typically is contained on an intranet or
SharePoint site? The following content, at min-
imum, has proven to be highly useful (a link on
the home page to the site and a separate page for
each topic):
• What’s New: A section to list the
most recent regulatory agency updates
(by country), provide links to recently
published newsletters, or to the
newsletter main page.
• Links to RI database and any other
databases or RI tools available
companywide: These include
regulations, guidelines, standards, forms,
templates by country, whether they are
final or draft.
• Research requests: These include
instructions and forms for the request
past and popular requests.
• Therapeutic area and product
approvals background: Strategy,
articles, competitive analysis, past
product precedents, drug approval/
summary basis of approval summaries,
presentations, etc.
• Training and presentations library:
Typically organized by subject and then
by category.
• Reviewer and inspector profiles:
Listing of all reviewers and inspectors
and links to their profiles
• Commenting: Items relevant to the
organization subject matter experts
who can provide a company perspective
for the impact analysis.
• Enforcement/inspection databases:
Inspector profiles can be stored here
as well as Warning Letters, inspection
outcome reports, and GXP trending
information.
• Articles: This can be a link to reference
managing software or can provide
articles the RI department considers to
be of interest not falling under the scope
of a therapeutic area or hot topic.
• RI department-related information:
Metrics, contact information for RI
personnel at affiliate offices with their
respective responsibilities listed.
Chapter 5: How to Set Up an RI Department
ities and differences as illustrated in Table 5-1.
How each company addresses their needs varies
based on experience, deliverables, and budget.
However, the RI process remains the same
regardless of size.
Outsourcing
Depending on the size of the RI department
and expected activities, outsourcing may be
a good option, at least on an ad hoc basis.
Outsourcing can solve resource availability chal-
lenges, including lack of competency or lan-
guage skills to monitor the regulatory landscape.
Outsourcing basic and repetitive activities can
free up time for internal staff to work on more
value-added activities.
Knowledge Management
How to Manage and Store Data and Data
Requests
RI output must be managed, stored, and shared
to learn from experience and avoid duplication
of effort. For small companies, an intranet site
(such as SharePoint) is an effective way to man-
age and share data, including requests. Larger
companies can use an intranet site or dashboard
and databases (in-house, custom or off-the-
shelf) and more-efficient systems for managing
information requests, fulfilling requests, posting
hot topics, and distributing new regulations or
guidance documents.
Intranet/SharePoint Site
What typically is contained on an intranet or
SharePoint site? The following content, at min-
imum, has proven to be highly useful (a link on
the home page to the site and a separate page for
each topic):
• What’s New: A section to list the
most recent regulatory agency updates
(by country), provide links to recently
published newsletters, or to the
newsletter main page.
• Links to RI database and any other
databases or RI tools available
companywide: These include
regulations, guidelines, standards, forms,
templates by country, whether they are
final or draft.
• Research requests: These include
instructions and forms for the request
past and popular requests.
• Therapeutic area and product
approvals background: Strategy,
articles, competitive analysis, past
product precedents, drug approval/
summary basis of approval summaries,
presentations, etc.
• Training and presentations library:
Typically organized by subject and then
by category.
• Reviewer and inspector profiles:
Listing of all reviewers and inspectors
and links to their profiles
• Commenting: Items relevant to the
organization subject matter experts
who can provide a company perspective
for the impact analysis.
• Enforcement/inspection databases:
Inspector profiles can be stored here
as well as Warning Letters, inspection
outcome reports, and GXP trending
information.
• Articles: This can be a link to reference
managing software or can provide
articles the RI department considers to
be of interest not falling under the scope
of a therapeutic area or hot topic.
• RI department-related information:
Metrics, contact information for RI
personnel at affiliate offices with their
respective responsibilities listed.