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