PV Training Material


At SJ Pharma Consulting, LLC in Mendham, NJ, we provide a course that covers all the essential components of drug safety and pharmacovigilance. These components include regulatory requirements, adverse event reporting, signaling, and risk management.

Furthermore, our course tackles the pharmacovigilance audit and has exercises in signaling and data mining. It explains the regulatory requirements of global government agencies that monitor drug safety.

With the diminished pipeline of drugs in development, keeping products on the market without interruptions becomes more crucial. Successfully navigating drug safety and pharmacovigilance is the key to regulatory compliance, consumer confidence, and product longevity.

Our course offers regulatory references, processes, best practices, and analysis and investigation techniques. These can help learners in minimizing risks, avoiding product recalls, and meeting international safety and reporting standards.

 

Course Outline

Module 1 – Overview of Pharmacovigilance
 
  • Learning Objectives for This Session
  • History of Pharmacovigilance
  • Pre-Marketed AEs
  • Post-Marketed AEs
  • Pre- and Post-Marketing: Basic Differences
  • The Importance of Adverse Event Reporting
  • Pharmacovigilance Definitions
  • ICH Definition of Adverse Event
  • ICH Definition of Adverse Drug Reaction
  • Suspected Unexpected Serious Adverse Reaction
  • Sources of ADRs
  • Pharmacovigilance Process
  • Assessing Adverse Events
  • Regulatory Definition of a Serious Adverse Event
  • Severity/Intensity
  • Difficulty Assessing Relationship of AEs With Drug
  • Causality
  • Lack of Efficacy – ICH
  • Expectedness
• Assessing Expectedness/Labeledness/Listedness
• Labeled vs. Listed
• Company Core Data Sheet (CCDS)
• Company Core Safety Information (CCSI)

  • General Types of Reports
• Expedited Reporting – What to Report
• Expedited Reporting – What Not to Report

  • Aggregate Reports – Common Types
  • Reporting Time Frames for ICSRs
  • Timelines for Follow-Up
  • Reporting to IRB/ECs
  • Investigator Notification
  • Minimum Criteria for Reporting
  • Minimum Data Set – Day “0”
  • Reporting Format
  • Key Data Elements for Inclusion in Expedited Reports
  • Managing Blinded Therapy Cases
  • Special Cases
  • Post-Study Events
  • Safety Signal Generation: Definition
  • Pharmacovigilance Process
  • Quiz on Module 1
Module 2 – Global Regulatory Requirements
 
  • Matrix of Safety Regulations
  • FDA Regulations
  • New FDA Regulation for IND Safety Reporting
  • International Conference on Harmonisation (ICH)
  • ICH Topic Codes and Reports
  • EudraVigilance – Pre-Marketing Requirements
  • EudraVigilance – Post-Marketing Requirements
  • IND Annual Report
  • Development Safety Update Report
  • New EU Pharmacovigilance Legislation
  • Quiz on Module 2
Module 3 – The Pharmacovigilance Audit
 
  • Overview of the Pharmacovigilance Audit
  • PV Checklist
  • Pharmacovigilance Risk Profile
  • Limited Diagnostic Can Initiate the Assessment
  • Case Study #1
  • Case Study #2
  • The Pharmacovigilance Audit: Key Themes
  • Overview
  • Eight Domains of PhV
  • Practical Tips from MHRA
  • References
  • Quiz on Module 3
Module 4 – Signaling and Risk Assessment
 
  • Signaling Overview
  • Regulatory Requirements
  • Signal Detection Objectives
  • Approach to Signal Detection
  • Approach to Signal Detection
  • Data Flow
  • Conclusion
  • What Is Data Mining?
  • Data Mining Methods
  • Bayesian Methodology (Used by WHO)
  • MGPS Methodology (Used by the FDA)
  • PRR – Proportional Reporting Ratio
  • Signal Detection Process Issues – Major Topics
  • Quiz on Module 4
Module 5 – Communicating Safety Issues
 
  • Pharmacovigilance Process
  • Signal Detection Operational Questions
  • Signal Detection Sources
  • Signaling Process
  • Signal Evaluation Steps
  • Signal Repository and Safety Profiles
  • Product Safety Profile (PSP)*
  • Sample PSP Information
  • Sample PSP Index
  • Risk Management Planning
  • RMP vs. REMS
  • EU-RMP Format
  • EU-RMP – Risk Minimization
  • REMS Elements
• Component of REMS – Mediation Guide
• Component of REMS – Communication Plan
• Component of REMS – Elements to Assure Safe Use
  • Conclusion