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In-Person Pharmacovigilance and Drug Safety Training Courses

All marketing authorization holders are now required to have internal PV audits of their pharmacovigilance operations. At SJ Pharma Consulting, LLC in Mendham,NJ, we provide drug safety and pharmacovigilance training courses that cover the US, EU, and ICH regulatory requirements.

Introduction to Drug Safety: US and EU Requirements

This training course is designed to give pharmaceutical and biologics companies operating in the US and EU an introduction to the fundamentals of product safety and regulatory compliance.

The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.

The course will also provide an introduction to the recent European pharmacovigilance requirements and provide important updates on regulations.

What You’ll Get

  • An Understanding of Regulatory Requirements for Drug Safety
  • Knowledge of How to Collect, Assess, Report, and Analyze Adverse Events
  • Overview of US and EU Regulatory Framework Including Details of EU GVP Modules
  • Requirements for Quality Oversight of Drug Safety
  • How to Conduct an Audit and Prepare for an Inspection
  • Contents of the PV System Master File (PSMF)
  • Requirements for Signal Management
  • Need for REMS and Risk Management Plans

Who Should Attend

Almost everyone involved in drug development and marketing needs to know the basics of the
FDA’s regulations regarding drug safety. Staff members who will benefit include

  • Drug Safety and Pharmacovigilance
  • Regulatory Affairs
    • Clinical Development Executives (Including C-Level) With Any Legal Responsibility for Drug Safety

    Course Outline

    Drug Safety Essentials

    • Brief History of Pharmacovigilance
    • Pre- and Post-Marketing: Basic Differences
    • The Importance of Adverse Event Reporting
    • Pharmacovigilance Definitions
    • Suspected Unexpected Serious Adverse Reaction
    • Sources of ADRs
    • Pharmacovigilance Process
    • Assessing Adverse Events
    • Regulatory Definition of a Serious Adverse Event
    • Severity/Intensity
    • Causality
    • Lack of Efficacy
    • Expectedness
    • Expedited and Aggregate Reports
    • Reporting to Ethics Committees and Investigators
    • Minimum Criteria for Reporting
    • Quiz

    US and EU Regulatory Requirements

    • Legalities US and EU
    • Matrix of Safety Regulations
    • Post-Marketing Safety Reporting
    • CFR
    • International Conference on Harmonisation (ICH)
    • Council of International Organizations of Medical Sciences (CIOMS)
    • Key EU Components
    • What Is Europe – EU, EEA, EFTA
    • EudraVigilance
    • Clinical Trials Directive
    • QPPV
    • DSUR
    • Signaling Regulations
    • Recent EU PV Legislation: GVP Modules and Implementing Measures, Quality Systems, Audit and Inspection, PV System Master File (PSMF), ADR Reporting (During the Transition Period and Final Arrangements), PSUR/PBRER, Signal Management, and Risk Management
    • Quiz

    Interactive Activities

    • Case Assessment: Seriousness, Severity, and Causality
    • Quiz on Drug Safety Essentials
    • Quiz on US and EU Regulations

    The Pharmacovigilance Audit: How to Prepare for an Inspection

    Course Outline

    Day 1: 8:30 AM – 5:00 PM

    Regulatory Background

    • Matrix of Safety Regulations
    • Post-Marketing Safety Reporting: CFR
    • International Conference on Harmonisation (ICH)
    • ICH Topic Codes and Reports
    • Council of International Organizations of Medical Sciences (CIOMS)
    • EudraVigilance
    • Clinical Trials Directive
    • Requirements of the Recent EU PV Legislation

    The Pharmacovigilance Audit

    • Overview of the Pharmacovigilance Audit
    • Typical Pharmacovigilance Current Process Model
    • Best Practice Approach to Enhancing Process Model
    • Achieving Best Practices Through the Pharmacovigilance Assessment
    • Value Derived
    • Scope
    • Company Sources of Information to Be Examined
    • PV Checklist
    • Audit Report Table of Contents
    • Limited Audit

    Series of Interactive Case Studies

    • Based on Five Real-World Inspections

    Pharmacovigilance Concepts

    • Premise, Signal Detection Hierarchy
    • Signaling Analyses
    • EU Signaling Legislation
    • Approach to Signal Detection
    • Signal Detection Process Issues
    • MHRA and Signal Detection

    Practical Tips

    • Importance of QPPV in Europe
    • Need for Oversight of the Pharmacovigilance System
    • Ensuring Information on Adverse Events Is Accessible
    • Suitability of People
    • Requirements for SOPs
    • Processing of ICSRs
    • Electronic Reporting
    • Periodic Safety Update Reports (PSURs)
    • Signal Detection Practical Tips
    • Quality Assurance

    Quiz Time

    • Mock Audit Case Studies
    • Requirements for Active Surveillance
    • Expedited Reporting in the US and EU
    • Qualified Person for Pharmacovigilance – What They Must Do
    • Signaling and Data Mining: Laws, Regulations, and Guidance in the US and EU

    Course Description

    This training course will give you a jump-start on how to prevent common problems that are found during regulatory inspections for drug safety and pharmacovigilance.

    It will include examples based on the top 10 findings by US and EU pharmacovigilance inspectors. You will be able to use this information straight away to make the changes you need to address these common failings and avoid the findings.

    You can be sure regulatory authorities will inspect your drug safety operations, and there is no excuse for poor preparation.

    This training course is designed to give pharmaceutical firms operating in the US and EU practical information, best practices, and insight to help ensure compliance with the most recent drug safety and pharmacovigilance regulations.

    Whether you’re planning an internal audit of your processes, anticipating an audit from a business partner, or preparing for your FDA or EMA inspection, this course will give both old hands and new staff the insights needed to be ready for regulatory scrutiny of your drug safety and pharmacovigilance specialists, safety processes, safety systems, and reporting.

    What You’ll Learn

    • The Top 10 Findings From US and EU Pharmacovigilance Inspections
    • Why the Pharmacovigilance Audit Is Important to Ensure Good Pharmacovigilance Practice
    • The Impact of Global Regulations on International Safety Reporting and Review Methods
    • The Objectives and Components of a Pharmacovigilance Audit
    • Practical Steps to Help You Begin and Implement Your Audit
    • The Requirements of All Applicable Regulatory Bodies for Your Products
    • Initiating Company Practices for Drug Safety Across the Product Lifecycle
    • Examples of What NOT to Do

    Who Should Attend

    • Clinical Safety Staff
    • Pharmacovigilance Specialists
    • Regulatory Affairs Professionals
    • Quality Management Specialists
    • Management Involved in Clinical Oversight

    Signal Detection and Pharmacovigilance

    Course Outline

    Day 1: 8:30 AM – 5:00 PM

    Part 1: Background to Signal Detection

    • Regulatory Requirements
    • Approaches to Signal Detection
    • Signal Detection Hierarchy
    • Layered Approach to Signaling
    • Statistical Versus Medical Significance
    • Signaling Analyses Specified by Good Pharmacovigilance Practices
    • Components of Suggested Analyses
    • How to Characterize a Suspected Signal

    Part 2: Signaling Examples

    • Signaling Case Study
    • Data Flow
    • Recommended Data Elements to Be Obtained Prior to Analysis
    • Typical PSUR Data Elements
    • Analysis by MedDRA System Organ Class
    • Analysis by MedDRA Preferred Term, Age Range, Sex, Country, Time to Onset, Treatment Duration, AE Duration, Concomitant Medications, and Dechallenge/Rechallenge
    • Describe Signal and Relate to Prior Signaling Exercises
    • Define Correlations Found via Prior Signaling Exercises

    Part 3: Data Mining

    • Definitions, Principles, and Methodologies
    • Challenges in Adverse Event Databases
    • Recommended Approaches
    • Components of Suggested Analyses
    • External Data Sources
    • Data Flow Elements
    • Bayesian Confidence Propagation Neural Network (BCPNN)
    • Multi-Item Gamma Poisson Shrinker (MGPS)
    • Proportional Reporting Ratio (PRR)
    • Which Data Mining Algorithm?
    • Comparison of Methods
    • Relative Timing

    Part 4: Risk Management

    • Pharmacovigilance Process
    • Operational Questions
    • Sources
    • Signal Evaluation Steps
    • Signal Repository and Safety Profiles
    • Product Safety Profile (PSP)
    • Risk Management Planning
    • Factors to Consider in Signaling Optimization
    • Signal Detection Triage Example
    • Triage Algorithms Used
    • Comprehensive Signaling Process Elements

    Interactive Activities

    • Signaling and Data Mining Analyses Based on Company and FDA Data
    • Analysis of AE Data by MedDRA System Organ Class, Preferred Term, Age Range, Sex, Country, Time to Onset, and Concomitant Medications

    Course Description

    This course will describe how to implement signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US.
    Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms.

    This course will cover signal assessment, use of signal triage algorithms, compliance with the FDA and EMA guidance as specified in the FDA’s “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment” and GVP Module IX, and the timing and frequency of signal detection, triage, and data mining runs.

    The course will also describe how to progress from signal detection through signal validation and signal management to risk assessment, risk management, and risk mitigation. Attendees will learn the components of both the EU Risk Management Plan (RMP) and the FDA’s Risk Evaluation and Mitigation Strategies (REMS).

    Learning Objectives

    • Understand the Basic Concepts and Principles of Signal Detection
    • Describe How to Apply These Techniques Within Your Company
    • Apply Data Mining Techniques to Analyze Large Volumes of Adverse Event Report Data
    • Manage Signals, Identify Safety Concerns, and Develop a Risk Management Plan

    Who Should Attend

    • Clinical Safety/Pharmacovigilance
    • Clinical Research and Development
    • Risk Management
    • Epidemiology