Aggregate reporting in pharmacovigilance refers to the process of compiling, analyzing, and submitting summarized safety and efficacy data for a pharmaceutical product to regulatory authorities at defined intervals after its approval. The purpose of aggregate reporting is to provide a comprehensive overview of the benefit-risk profile of a drug or medical product once it is on the market. This process helps regulatory agencies monitor the safety of products and make informed decisions regarding their continued marketing authorization. Here are key aspects of aggregate reporting in pharmacovigilance:

1. Welcome
Aggregate Reporting in Pharmacovigilance
Name: Sk Mohin
Qualification: M. Pharmacy
Student ID: 153/082023
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2. Index
 Introduction
 Aggregate Reporting
 Sources For Aggregate Reporting
 Objectives
 Types Of Aggregate Reports
 Key Terminologies And Submission Of Schedules
 Regulatory Requirements For Aggregate Reporting
 Demonstrating The Impact Of Aggregate Reporting
 Conclusion
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3. INTRODUCTION
 Pharmacovigilance (PV) is the science and activities
related to the detection, assessment, understanding, and
prevention of adverse effects or any other drug-related
problems whereas
 Aggregate reporting is a crucial part of pharmacovigilance,
as it involves the systematic analysis and submission of safety
data collected from various sources. It is a vital process in
post-marketing surveillance to ensure ongoing monitoring of
drug safety.
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Importance of
Aggregate
Reporting
Continuous
Surveillance
Detecting
Emerging
Safety
Signals
Assessing
Benefit-Risk
Balance
Regulatory
Compliance

4. AGGREGATE REPORTING
 A review of cumulative safety data from medicinal products obtained from a wide range of sources,
on a periodic basis and submitting these findings to regulatory agencies worldwide.
 These safety reports are presented to regulators as soon as the medicine is marketed anywhere in the
world and enable an understanding of the risk and benefit profile of the product over a period of time.
 It emphasizes the process of collecting, analyzing, and summarizing safety data over time.
 These reports focus not so much on individual cases, but rather on overview, assessment of the safety
profile, and benefit-risk-evaluation of Adverse Drug Reaction (ADR) and the Serious Adverse Event (SAE)
and pregnancy reports.
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5. SOURCES FOR AGGREGATE REPORTING
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Clinical Studies
Spontaneous reports by HCPs,
patients, etc.
Literature Reports
ADR reporting systems of
Regulatory Health Authorities

6. OBJECTIVES
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Periodically assess and update global safety data for a
drug before and after approval.
Summarize safety data and assess benefit-risk profile to
identify potential safety concerns.
Further investigation of the product.
To comply with the regulatory guidelines.
Changes to the approved medicinal product label in order
to provide up-to-date information.

7. TYPES OF AGGREGATE REPORTS
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Pre-Marketing
Report
Post-Marketing
Report
IND annual reports in the USA (still
accepted)
Clinical study reports (CSR)
Development Safety Update Report (DSUR)
Annual safety reports (ASRS) in Europe (no
longer accepted)
NDA and ANDA annual reports
Periodic Benefit Risk Evaluation Report
(PBRER)/Periodic Safety Update Report(PSUR)
Periodic Adverse Drug Experience Report
(PADER)/Periodic Adverse experience report
(PAER) in the US
Addendum to clinical overviews (ACO) for
renewals in Europe

8. KEY TERMINOLOGIES AND SUBMISSION OF SCHEDULES
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 Development International Birth Date
(DIBD) - The date authorization is obtained
to conduct clinical trials in any country.
 International Birth date (IBD)- The date
of the first marketing authorization, the EU
birth date is the date of the first authorization
in Europe.
 Data Lock Point (DLP)- The cut-off date
for data to be included in the DSUR.
 Reference Safety Information (RSI)- A
document containing a cumulative list of all
the adverse events observed.
Report Type Submission Frequency
Timeline (Post
DLP)
DSUR Yearly 60 Days
PSUR
6 monthly for the first 2 years
Yearly for the next 2 years
Three yearly from then onwards
60 Days
PBRER
(Newly
approved
product)
06 monthly for the first 2 years; yearly
from then onwards
70 Days (Annual)
90 Days
(multiyear)
PADER
quarterly for the first 3 years then;
annually until all the approval of the
product withdrawn
30 Days
(Quarterly)
60 Days (Annual)

9. REGULATORY REQUIREMENTS FOR AGGREGATE
REPORTING
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• Serious and
unexpected
adverse events
are reported
Data
Collection
• Data are collected and
entered in the
database i.e. results
of the investigation
and result, cause, and
outcome
Data entry in
database • Adverse reaction
monitoring center
(AMC) manages drug
safety information,
clinical safety data
Case
processing
• Evaluate the
cumulative safety
information from
wide range of
source on
periodic basis
Aggregate
reporting
• USFDA (USA)
• EMA (Europe)
• CDSCO (India)
• MHLW (Japan)
• Australia (TGA)
Submit to
regulatory
authority

10. DEMONSTRATING THE IMPACT OF AGGREGATE
REPORTING
Scenario:
A hypothetical pharmaceutical company, MedoIn
Pharma, launched a new anti-inflammatory
medication called "InflaSafe." Clinical trials
showed positive results in reducing inflammation,
leading to marketing approval.
Emergence of a Safety Concern:
Following the market launch, healthcare
professionals report isolated cases of
gastrointestinal bleeding in patients using
InflaSafe.
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Importance of Aggregate Reporting:
• Data Collection
• Signal Detection and Aggregation
• Aggregated Data Analysis
• Signal Evaluation
• Regulatory Engagement
• Regulatory Action
• Benefit-Risk Assessment
• Label Update and Communication
• Outcome

11. Continue..
1. Data Collection:
MedoIn Pharma collects individual adverse event reports of gastrointestinal bleeding related to InflaSafe from
various sources.
2. Signal Detection and Aggregation:
Through regular aggregate reporting, MedoIn Pharma's pharmacovigilance team notices a consistent rise in
reports of gastrointestinal bleeding.
3. Aggregated Data Analysis:
Analyzing the aggregated data reveals a pattern – an increased frequency of gastrointestinal bleeding cases
compared to other anti-inflammatory drugs.
4. Signal Evaluation:
MedoIn Pharma intensively investigates the signal's significance by considering factors such as patient
demographics, dose variations, and concurrent medication use.
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5. Regulatory Engagement:
Recognizing the importance of early intervention, MedoIn Pharma proactively submits a Periodic Safety Update
Report (PSUR) to regulatory agencies, detailing the emerging signal.
6. Regulatory Action:
Regulatory authorities review the PSUR and corroborate the safety signal with their own adverse event data.
7. Benefit-Risk Assessment:
The regulatory agency initiates a comprehensive benefit-risk assessment of InflaSafe, considering the new
safety signal alongside the drug's therapeutic benefits.
8. Label Update and Communication:
Based on the assessment, the regulatory agency mandates a label update to include gastrointestinal bleeding as
a potential side effect of InflaSafe. Healthcare professionals and patients are informed about safety concerns
through updated product labeling.
Continue..

13. CONCLUSION
 Aggregate reporting in pharmacovigilance is crucial for assessing the safety of
medicinal products.
 It helps identify safety signals, inform regulatory decisions, and ensure patient safety.
 This mechanism plays a significant role in safeguarding public health.
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14. Thank You!
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(India | Canada)
9121151622/623/624
info@clinosol.com
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