Summary Tabulation | PharmaBharat Tools

Loading term…

About Us Contact Us Disclaimer Privacy Policy Terms and Conditions

© 2026 PharmaBharat. All rights reserved.

Summary Tabulation | PharmaBharat Tools

Categories

Aggregate Reporting(35)

Periodic Benefit-Risk Evaluation Report(PBRER)Development Safety Update Report(DSUR)Aggregate Report ICH E2C(R2) PBRER Periodic Report Schedule Data Lock Point(DLP)Cumulative Safety Data Exposure Estimate Line Listing Summary Tabulation Integrated Summary Safety(ISS)Meta-Analysis Safety Cumulative Case Count Reporting Rate Safety Data Sheet Addendum Report Annual Safety Report(ASR)Benefit-Risk Analysis (Aggregate)Periodic Safety Reporting for Clinical Trials Cumulative Summary Data Lock Point(DLP)Development Safety Update Report(DSUR)EU Reference Date(EURD)Patient Exposure Data International Birth Date(IBD)Interval Data Line Listing Periodic Adverse Drug Experience Report(PADER)Periodic Benefit-Risk Evaluation Report(PBRER)Proposed Product Information Changes Periodic Safety Update Report(PSUR)PSUR Repository Safety Specification Single Assessment Summary Tabulation

AI & ML in Pharmacovigilance(21)

Audit & Inspection Readiness(30)

Audits & Inspections(20)

Case Intake & Triage(42)

Case Processing & Data Entry(49)

India CDSCO & PvPI(20)

Data Privacy & Masking(21)

GVP & ICH Updates 2026(9)

Medical Review(26)

Quality Review(46)

Real-World Data & RWE(21)

Regulatory Harmonization(12)

Regulatory Reporting(83)

Risk Management(68)

Seriousness & Causality Assessment(34)

Signal Detection & Validation(43)

Signal Management(20)

Progress

0%

PV Aggregate ReportingSummary Tabulation

Loading term…

Line Listing Integrated Summary Safety (ISS)

Summary Tabulation

Aggregate Reporting

Definition

Summary tables (e.g., by SOC, seriousness) in periodic reports.

Example

AE summary by preferred term in PBRER.

Regulatory source

ICH E2C(R2)

Related terms