This document discusses the evolution of pharmacovigilance (PV) and the need for a unified safety platform to address current challenges. It notes that PV currently focuses on compliance but lacks agility and innovation. There is also low technology maturity and high manual effort. Looking ahead to 2030, the role of safety will need to be reimagined to integrate more data sources, enhance patient involvement, and support predictive and personalized treatments. A unified safety system on a cloud platform could help by integrating data from across the product lifecycle, streamlining processes, and enabling greater collaboration.

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Copyright © Veeva Systems 2021
Reimagine Patient Safety 2030
Oversight and Medical Governance
Through a Unified Safety Platform
Sharmila Sabaratnam, Senior Director
Vault Safety Strategy, Europe

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Copyright © Veeva Systems 2021
Sharmila Sabaratnam
SD, Vault Safety Strategy, Europe
Sharmila Sabaratnam is a Senior Director at Veeva Systems responsible for EU SMB Vault Safety Strategy helping
customers to transform their business through unified safety platform adoption. Physiologist by training with research
experience within oncology and arthritis. She has 10+ years’ experience within safety, previously leading safety and
regulatory advisory services for Top-25 and Top-100 companies within Ernst & Young and Navitas. Her experience
includes operating model design and safety strategy, PV automation, benefit-risk management and performance
benchmarking. As a senior leader within the NHS, led R&D clinical operations with a large oncology clinical trials
portfolio, including the Biomedical Centre for Translational Research.
Linkedin Details - www.linkedin.com/in/sharmila-sabaratnam-709b6a7

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Copyright © Veeva Systems 2021
Agenda
PV Evolution and Challenges
1
PV2030: Reimagine Role of Safety
2
Future Technology Needs for Safety
3

4. PV Evolution and Challenges

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Low Organisational Visibility and Compliance Focus
15%
CAGR
Solicited cases, non-
serious cases,
consumer reports
Dollars
Outsourcing and vendor
oversight
$Millions
LOW
AGILITY AND
INNOVATION
ANNUAL
CASE
GROWTH
>60%
GROWTH
EXTERNAL
SPEND
LOW
PV TECH
MATURITY &
HIGH
SWITCHING
COSTS
Low tech maturity
to enable R&D
data integration
and insights
BENEFIT - RISK (B-R)
High manual effort
and operational
spend
>60%
B-R
COMMUNICATION
.….
<30%
PV Budget….

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Pressure to Optimise B-R for Patients and R&D Outcome
Safety
Organization
Focus on Patient Centricity
• Patients are more aware and
actively involved
• Customized medication and
therapies
• Enhanced quality of life / outcome
• Patient voice in regulatory decisions
Disruptive Healthcare Trends
• New healthcare delivery models e.g.
Drones, telemedicine, wearables
• New entrants e.g. Amazon, Google
Health, 23andMe
• Healthcare costs, payers and
providers role in future
Disruptive R&D Models
• Early access / licensing
• Decentralised trials
• Personalised / targeted therapies
• Increasing RWE / post-market data
Divergent Regulatory Demand
• EU/US, ICH and RoW PV regs
• Growing QPPV, PSMF, local data req
• Converging drugs, devices,
diagnostics patient safety /
performance monitoring
B-R Data Explosion: Volume,
Variety & Speed
• Safety data focus is more than just
AEs (e.g. medication errors, lack of
efficacy, effectiveness, supply,
quality)
• Emerging safety issues: Local-Global

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Forward Look PV2030: PV Ecosystem Disruption
Reimagine
Role of
Safety
Regulatory Innovation
On Market Performance Enhanced Patient
Involvement
Data Abundance and
Federated Data Governance
Predictive, Preventative, and
Personalised Treatments
https://ec.europa.eu/health/ehealth/dataspace_en
https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-
strategy#regulatory-science-strategy-to-2025-section
https://www.fda.gov/drugs/news-events-human-drugs/fda-approval-
demonstrates-role-real-world-evidence-regulatory-decision-making-drug-
effectiveness
https://www.england.nhs.uk/genomics/nhs-genomic-med-service/
https://ec.europa.eu/health/md_eudamed/overview_en
https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-
focused-drug-development-guidance-series-enhancing-incorporation-patients-
voice-medical
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/atta
chment_data/file/1022370/Patient_involvement_strategy.pdf

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Patient Safety Metrics Will Become Key Focus for Enterprise
Risk & Medical Governance
PV Enterprise Risk
Safety is now a key functional domain
for enterprise risk reporting and
annual report disclosure.
Regulators Engagement
Early alignment with regulators on
automation and new ways of
working.
Virtual Network & Partnership
Decentralised healthcare models
driving new R&D models; safety needs
to adopt new ways of working.
Executive Sponsorship
Chief Medical Officers, Safety Officers
Chair Medical Governance, QPPV
Accountability.
Data Economy, Data Risks
Emerging regulations for managing
Healthcare data and providing access to
patients to drive health decisions. Data
integrity and risks increasing.
Role of Technology
Integrated fabric of lifestyle; real-time
data collection. Risk stratification,
population targets, diagnosis,
treatment and monitoring continuum.

9. Future Technology Needs

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Ability to Integrate and Analyse Lifecycle B-R from Internal
and External Sources Will Be A Key Driver
Basic
Research
Drug
Discovery Pre-Clinical
IND
Submitted
NDA/BLA
Submitted
Agency
Approval
Clinical Trials
Phase I Phase II Phase III
Agency
Review
Post-Approval
Research & Monitoring
Phase IV
Product
Lifecycle
Insight
Real-time benefit-risk
evaluation & strategy
Proactive surveillance leading
to predictive/preventative
models
Faster time-to-market
with patient safety as a
‘competitive advantage’
Direct patient participation
and enhanced patient
experience; on market
performance monitoring
Data
Data
and
Content
Sales Data
Claims
Safety Biomarkers, Clinical Trial Data
Pharmacovigilance Data
Regulatory Data – FAERS, VAERS, VigiBase, EudraVigilance, JADER, MedDRA, WHO Drug
Medical Literature
Animal Testing,
Safety Biomarkers
API
Information
Patient Registries,
EMR/ EHR
Social Media
Continuous feedback loop and rethink to influence outcome

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Unified and Connected Pharmacovigilance Solution
Aggregate or
Periodic Reporting
Case
Intake
Partner
Management
Content
Management
Case Processing
and Management
Submissions and
Distribution
Signal & Risk
Management
Artificial Intelligence, Reporting, Analytics, Dashboards
Other Data
Sources
Partners
Other
Functional
Areas
•Cloud Platform
Unified Safety System
Regulators
Patients Consumers
Other

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Clinical
Operations
Clinical Data
Management Regulatory Quality
Clinical Sites
Medical
Comms
Integrated Safety Vision Can Help Address Top-5 Issues
Periodic Reports
Quality Complaints
Safety Letters
Adverse Events and Queries
Adverse Events, Queries and Reconciliation
Adverse Events
Products, Labels
Clinical Info
Safety
Cloud Platform
Trial issues
impacting safety
medical
monitoring / B-R
communication
Product quality
complaints / HCP
queries
Counterfeit
Drugs /
Manufacturing/
Lack of Supply/
Labelling Issues
Product
Registration Data
(MAA, Var),
IDMP, M&A
Reference Safety
Information:
Signal to Label
Patient
Experience Data
- Future Growth
1
2
3
4
5

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Value for Pharmacovigilance
Improving PV with
Modern Technologies
Reduce System Operational Costs
• Simplify IT system landscape with
modern cloud solutions
• Makes it easier to stay current with
regulations and technology
Streamline Processes
• Combine data, content, workflows
• Leverage automation, AI, and machine
learning
Enable Greater Data
and Content Visibility
• Implement secure and global data
access
• Adopt data standards
• Provide consistency & transparency
• Leading indicators & risk mitigation
Support Collaboration
• Enable digitised processes across
functional areas
• Promote sharing of data and content
across internal and external parties
Better Partner Alignment
• Enable oversight
• Controlled processes
• Real-time data entry
• Data traceability

14. Thank you
Questions?
Please contact:
sharmila.sabaratnam@veeva.com