The document discusses the evolving landscape of Individual Case Safety Reporting (ICSR) and pharmacovigilance, highlighting the challenges and opportunities presented by technology, data standardization, and regulatory changes. It emphasizes the need for a unified and connected pharmacovigilance solution to manage data and content effectively, streamline processes, and enhance collaboration. The document outlines the benefits of modernizing ICSR reporting, including improved efficiency, compliance with regulations, and better management of adverse drug reaction data.

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Copyright © Veeva Systems 2021
Reshaping Global ICSR Reporting to
Deliver Real-time Visibility and Oversight
Saba Darvesh, Sr. Director Vault Safety Strategy
Mike Kruczek, Director Vault Safety Strategy

2. Saba Darvesh
Sr. Director, Vault Safety Strategy
Mike Kruczek
Director, Vault Safety Strategy

3. Global ADR
Data and Trends

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Copyright © Veeva Systems 2021
ICSR Volume Data
FDA FAERS Public Dashboard (Mar 2021)

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Copyright © Veeva Systems 2021
ICSR Volume Data
EMA PV Annual Report (2020)
Figure 2 – Trend of ADR reports from patients and consumers received
in the EEA by NCAs and MAHs and reported to EudraVigilance
EudraVigilance continues to
support the reporting of suspected
unexpected serious adverse
reactions (SUSARs) in accordance
with EU clinical trial legislation14
(see Annex II)

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Copyright © Veeva Systems 2021
ICSR Volume Data
NMPA PV Annual Report (2020)
1800000
1600000
1400000
1200000
1000000
800000
600000
400000
200000
0
Figure 1 - Trend in the number of reported adverse drug reactions / events nationwide from 1999 to 2020
Figure 3 - Source of adverse drug
event reports for 2020

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Uppsala Monitoring Centre
Annual Report Jul 2019 – Jun 2020
Additional Statistics from VigiBase
Country distribution for ICSRs received over the year
Country distribution in VigiBase for ICSRs received
during the past 12 months, as of 30 June 2020
ICSRs per Million Inhabitants
ICSRs received in VigiBase 2015 – 2020
(average to compensate for year-to-year fluctuations)

8. A Rapidly Evolving
Global Reporting Landscape

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Evolving Global Reporting Landscape
Evolving Regulatory
Guidelines
File
Formats
Data Integrity
and Timeliness
Solicited
Monitoring
Unsolicited
Monitoring
(PSP’s, SM, MLM)
Data Quality
Enhanced
Oversight and
Management

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Evolving Global Regulatory Landscape
2001
EudraVigilance
Created
2012 2017 2018 2019 2020 2021
New EU GPV
Guidelines
Adopted
New
EudraVigilance
Format
China ICH
Guideline
Adopted
2016
ANVISA (Brazil)
ICH Guideline
Adopted
FDA IND
Cross
Reporting
China GVP
Brazil
VigiFlow
Rollout
FDA PBRER
Adopted
Mexico R3
(Cofepris)
PMDA
R3
Korea
MFDS R3
EMA R3
Brexit –
MHRA
Russia, TGA,
SAHPRA
Updates
FDA
Combo
Products
FDA E2B R3,
eVAERS, eMDR
Health
Canada R3

11. Looking to the Future
Simplifying Global Reporting

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Analysis
Reporting & Metrics
Processing
Intake
Oversight & Management
Submissions
Gateway
Current PV System Landscape
Signal
Tracking
Local
Reporting
Business Objects
– Case
Management
Cognos, Qlik –
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

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Challenges
Current PV System Landscape
Opportunities
• Technology
 Secure and manage data easily
 Maintaining data privacy
 Translation engines
 Analytics and Visualization of multi-
dimensional data
• Standardization
 Data format - E2B R2/R3
 Coding of medical products and events -
MedDRA (EMA, FDA), WHO DRUG, ATC
• Multiple data sources
• HQ & Affiliate model – siloed data sources
• Unstructured data
• Inconsistent coding
• Different languages
• Separate data and content systems
• Data Governance & Management

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Copyright © Veeva Systems 2021
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 R&D Platform
Unified Safety System

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Traditional ICSR Reporting Process
Reporting & Metrics
Processing
Intake
Submissions
Gateway
Local
Reporting
Business Objects –
Case Management
Cognos, Qlik –
Metrics & user
reporting
Receipt &
Triage
Reconciliation
Log & Track
Safety Support
Issues
Japanese Safety
Database
Safety
Database
Dictionary &
Coding
Management
Safety
Database
Copy
Literature
Assessment
Follow-up Letters,
Clinical Queries
& Tracking
Aggregate
Reporting

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Copyright © Veeva Systems 2021
Modern ICSR Reporting Process
Reporting & Metrics
Case Review
Intake & Processing
Submissions
Gateway
Global
Reporting
Metrics & O
Metrics & user
reporting
Receipt, Triage, Data Entry
Safety
Database
Follow-up Letters,
Clinical Queries
& Tracking
Aggregate
Reporting
QC & Med Review, Submission
Multilingual
Multilingual
Local
Reporting
Dictionary &
Coding
Management
CAPA
Tracking

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Modern ICSR Reporting Process -
Identify and Review Late Submissions

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Modern ICSR Reporting Process -
Analyze Late Submissions

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Copyright © Veeva Systems 2021
Integrated with clinical,
regulatory and quality systems
Accessible from anywhere
and with any device
One source of the truth
Advanced automation and
intelligence
Unified Accessible Integrated AI
Cloud Always current with regulations
and new technologies
Power of a Unified Solution
Seamless Management of your Data & Content

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Copyright © Veeva Systems 2021
Cloud Always current with regulations
and new technologies
AI and
AUTOMATION
DATA ANALYSIS CONTENT
Case Processing
Reporting
Submissions
Signal Detection
& Analysis
Risk Management
Content Management
Process Management
Intake
Data Entry
Follow-up
Unified Solution - PV Process Transformation

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Benefits to the Industry
Technology Enabled
Simplified
ICSR Reporting
Simplified IT system
Landscape
Adaptive and
Scalable
Process Optimization
and Efficiency
Enhanced Collaboration and
Safety Content Management
Support Global and
Regional Reporting

22. Questions

23. Thank you
• Mike Kruczek
• Director, Vault Safety Strategy
• Mike.Kruczek@veeva.com
• (586) 216-8105
• Saba Darvesh
• Sr. Director, Vault Safety Strategy
• Saba.Darvesh@veeva.com
• (646) 463-2919