New technologies and approaches to safety and pharmacovigilance are enabling end-to-end processes for greater collaboration and oversight. During Pharmacovigilance World 2021, Jen Markey, VP Vault Safety Strategy Europe, shared how you can leverage a unified PV solution to improve outsourcing, streamline safety, and make compliance easier. For more information visit: www.veeva.com/eu/products/vault-safety

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Copyright © Veeva Systems 2021
Transforming Safety with
End-to-end PV Solutions
Jen Markey, VP Vault Strategy, Europe

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Copyright © Veeva Systems 2021
To improve is to change;
to be perfect
is to change often.
Winston Churchill

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Copyright © Veeva Systems 2021
Copyright © Veeva Systems 2020
Perception vs. Reality
Safety Database
90%
Other Stuff
10%
Perception: The safety
database provides most
of the PV solutions we
need

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Copyright © Veeva Systems 2021
Copyright © Veeva Systems 2020
Perception vs. Reality
Reality: There are many
different technology
solutions used to meet
all your PV needs
Safety Database
40%
Other Stuff
3%
Intake
5% Translation
3% Literature
3%
Japan DB
3%
BI / DW
5%
Surveillance
3%
Signal Detection
3%
Analytics
3%
RWE
3%
Doc Mgt
5%
Sharepoint
3%
Network Drives
3%
Email
5%
MS Office
3%
PSMF
3%
Risk Mgt
3%
PVAs
3%
Tracking
3%
Compliance
3%

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Copyright © Veeva Systems 2021
Analysis
Reporting & Metrics
Processing
Intake
Oversight & Management
Submissions
Gateway
What Does a PV System Architecture Look Like Today?
Signal
Tracking
Local
Reporting
Business
Intelligence – Case
Management
Business
Intelligence –
Metrics & user
reporting
Signal
Detection
Case
Analysis
Signal
Management –
Real Time
Analysis of
Clinical Cases
Compliance
Tracking &
Remediation
PV Agreements
Tracking
Receipt &
Triage
Reconciliation
Log & Track
Safety Support
Issues
Japanese Safety
Database
Safety
Database
Dictionary &
Coding Mgt
Safety
Database
Copy
Data Mart
PSMF, Local Trackers,
Safety Letters,
Investigator
Communications
Document
Management
ROW
Document
Management
EU
Literature
Assessment
Follow-up Letters,
Clinical Queries
& Tracking
Aggregate
Reporting
Data Duplication Separation of Data & Content Integration Nightmare! Significant Time & Effort

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The Reconciliation Issue
Product Registrations
& Labelling Updates
PQC with AE Medical
Enquiries
Clinical
SAEs
Clinical Regulatory Safety Quality
Medical
Communications

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Copyright © Veeva Systems 2021
What if… ?
You could
meet most of
your safety
needs with
one solution?
You didn’t
have to
reconcile
data between
systems?
You didn’t have
to use up
valuable safety
resources on IT
upgrades?
You always had
access to the
most up to date
reference data?
Your
transactional
processes
were
automated?
You could
automate
instead of
outsource?

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Copyright © Veeva Systems 2021
Unification on a Cloud Platform
AI and
AUTOMATION
DATA ANALYSIS CONTENT
Data and AI
• Determine case trends
• Automate intake
• Touchless Case Processing
• Move from manual to automated and
eventually predictive
Data and Content
• PSMF and tracking of content
• Risk management plans link to signal detection and labelling
• PV agreements link to compliance metrics
Data and Analysis
• Same data source to conduct
Signal analysis and assessment,
aggregate & operational reporting
Analysis and Content
• RMP
• REMS
• Signal assessment documentation
Automation and Content
• “Smart content” – maintain once, reuse multiple places
Cloud Always current with regulations
and new technologies

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Clinical
Operations
Clinical Data
Management Regulatory Quality
Pre-Clinical Commercial
Integrating Across Functional Areas
Periodic Reports
Quality Complaints
Safety Letters
Adverse Events and Queries
Adverse Events, Queries, and Reconciliation
Adverse Events
Products
Controlled Docs (PSMF)
Clinical Info
Safety
Cloud
Study, Country,
Site Master Data Product, Study, Site Master Data
Post Approval Change
Management
SOPs, Clinical Issues
Data Listings, Data Sets

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Copyright © Veeva Systems 2021
Unified and connected
to support the core of drug
development and manufacturing
Streamlined
information flow
High data quality
New level of productivity
Comprehensive, best-of-breed
set of applications
on a single cloud platform

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Copyright © Veeva Systems 2021
Copyright © Veeva Systems 2020
Transformation is
hard…

12. Questions

13. Thank You
Questions?
Contact Jen Markey (jennifer.markey@veeva.com)
or visit: veeva.com/eu/products/vault-safety