Case study | Clarivate Regulatory Intelligence Tracking Application

Gedeon Richter

Gedeon Richter Plc. isa major pharmaceutical company
headquartered in Budapest, Hungary.

Our client has an expanding direct
presence in Western Europe,
Mainland China, Latin Americaand Australia. Its product portfolio
covers many important therapeuticareas, including women's healthcare
as well as central nervous systemand cardiovascular areas. With
its widely acknowledged steroid
chemistry expertise, Gedeon
Richter is a significant player
in the women's healthcare
field worldwide and is active inbiosimilar product development.

The situation
A need to streamline businessspecific regulatory monitoringand impact assessments.

Each day, thousands of regulatory and industry-related
documents are released from different regions andcompanies all over the world. Before partnering withClarivate™, Gedeon Richter teams would spend hours
manually triaging these regulatory documents toidentify and communicate impacts across theirorganizations. This required a significant amount oftime to sift through multiple regulatory intelligencesources to identify and locate essential data.
Gedeon Richter staff would travelto the sites of EMA (EuropeanMedicines Agency), FDA (FederalDrug Administration) and otherregulatory authorities to manuallyreview updates in regulations orguidelines. These documents would
be downloaded and sent manually
via email to subject matter experts.
This proved inefficient because:• During regulatory triage, there
is a massive time investment asregulatory intelligence experts
scour each individual site andrepository. Each region has its own
storage solution, and it is difficult
to collect information globally.

2• Only the recipients of the email
would be aware of specificchanges. The changes inregulations and guidelines are
not searchable by others who
may need them unless a storage
solution is created to house them,which requires regular updates.
• The risk of documents beingout of date increases as people
tend to save local copies
rather than reference the mostcurrent versions available.

How Clarivate helped
Gedeon Richter is one of the earliest subscribers
to the Clarivate Regulatory Intelligence Tracking
Application. This end-to-end solution helps
organizations manage regulatory intelligenceby providing a single source of truth, unifying
data and making that data more actionable.
The Clarivate solution has helped empower
professionals at Gedeon Richter to think andact more strategically by providing the following.

3

Customizable dashboard thatdelivers the regulatory update
data specific to regions and topics
of interest — all in one place.

Solution powered by AI that
automates the daily processing of
new regulations and legislation,saving valuable time in triaging.

Notification and alerting systemthat keeps their experts up todate on the latest regulatory
requirements around the world— allowing them more time foraction and impact assessments.

Searchable storage solution that
consolidates regulatory updates
on a global level — one single
source of truth that increases
visibility and collaboration
across their organization.

Source for all departments
and experts to complete andview impact assessments.

Automated method of delivering alerts
and newsletters, increasing visibility
on regulatory updates and changes.

The impact
After using the tracking applicationfrom Clarivate for many years, Gedeon
Richter recognized the value that thissolution provides and is expanding
its use within its organization.
Now with unified data sources fromClarivate, Gedeon Richter has more
visibility into regulatory changes.
The company saves valuable timepreviously lost to manually triaging
data, and instead can reinvest its
time on higher value activities suchas actions and impact assessments.
Gedeon Richter’s key roles andexpert teams are integrated throughthe tracking application from

Clarivate, providing visibility into
subject matter expert assignments
and impact assessments that arealready completed. With the ability toautomate their newsletters with ease,
Gedeon Richter is able to include
the relevant and neccesary data to
notify its experts in a timely matter.
Technology and regulatory consultantsfrom Clarivate provided full support
during Gedeon Richter’s transition
into the tracking application. Clarivate
was able to leverage Gedeon Richter’s
global regulatory knowledge andtechnological expertise to help thecustomer improve its efficiency andexpand its usage of the application.

Putting new improvements to work
The latest features that Clarivate
consultants have delivered for
Gedeon Richter include:• Self-service user subscription
to notifications created by theadmin using the user profile
icon. This change allows experts
to opt in to alerts that impact
them directly. It also removes theadministrative burden of manuallyassigning these notifications.
• Auto-status mapping rules forone-step publication to daily
updates from pre-publication
triage. This feature saves morethan four clicks per document,
which multiplied by the hundredsof daily documents to triage, isa quality-of-life and time save.
• Auto-prioritization rules basedon reviewer question responses
mapped to custom priorities

4(i.e., “business impacted”).
This provides more visibility
across experts and teams
working together within
the Clarivate solution.
Clarivate solution teams areconstantly enhancing thetracking application to provide
more quality-of-life features.
This solution is configurable on
demand, but there is a pathway forincremental releases as all features
are opt-in and can be activatedbased upon business needs.
With the Clarivate Regulatory
Intelligence Tracking Application,
Clarivate consultants provide
Gedeon Richter with a customized
consulting experience that adds
in automations, shortcuts, rules
and new features, all without theneed for timely build cycles andre-releasing the entire application.

BXD1284019077 / 05

"Clarivate has been very
approachable and responsive
to taking our business needs
into consideration when working
with the tracking application.
We are now able to efficiently
triage and manage our regulatory
alerts, send out newsletters withease and so much more!"
Kinga Pallay,
Regulatory Intelligence Expert, Gedeon Richter

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