USFDA & EU ESSENTIALS OF DRUG SAFETY AND PHARMACOVIGILANCE

Description

 

About Speaker:

 

Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB was acquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant.

 

Lecture 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

 

Lecture 2: Assessing Adverse Event Cases

„ 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

Lecture 3: Reporting Adverse Events

„ General Types of Reports

„ Expedited Reporting – What to Report

„ Expedited Reporting – What not to report

„ Aggregate Reports – Common Types

„ Reporting Timeframes 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

Lecture 4: Global Regulatory Requirements

„ Matrix of Safety 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

„ Annual Safety Report

„ IND Annual Report

„ Development Safety Update Report

„ New European Pharmacovigilance Legislation

Lecture 5: Inspections and Audits

„ Audits vs Inspections

„ Why Conduct Them?

„ Types of Audits & Inspections

„ Who Can be Audited?

„ Approaches

„ Preparing for a Pharmacovigilance Inspection

Lecture 6: Pharmacovigilance Best

Practices

„ Achieving Best Practices through the

Pharmacovigilance Audit

„ Value Derived

„ Scope

„ Pharmacovigilance Process Model

„ Audit Items - Collection

„ Audit Items - Assessment

„ Audit Items - Reporting

„ Audit Items - Analysis

„ Additional Audit Items (1)

„ Additional Audit Items (2)

„ Company Sources of Information to be Examined

„ PV Checklist

Lecture 7: Preparing for an Inspection

„ Pharmacovigilance Risk Profile

„ Priority of Findings

„ Report Table of Contents

„ Limited Diagnostic Can Initiate The Assessment

„ Assessment Approach

„ Workflow/Processes-Global

„ Processes-CRO

„ Data Assessment

„ Personnel Qualifications & Training

 

Lecture 8: Case Studies with Real-Life Inspection Findings

„ Representative Findings from Case Study

„ Four Case Studies

„ Critical Issues Observed

„ Major Issues Observed

„ Tips for the Pharmacovigilance Audit

„ Eight Domains of PhV

„ Inspection Findings

„ How to Address Inspection Findings?

 

Lecture 9: Background to Signal Detection

„ The need for signal detection

„ Regulatory Requirements

„ Approach to Signal Detection

„ Company Characterization

„ Characteristics of small versus large companies

„ Premise for Signal Detection

„ Importance of astute clinical perspective

„ Danger of over-reliance on technology

„ Detailed characteristics

„ Elements of case series analysis

 

„ Lecture 10: Signalling Exercises

„ 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

„ Analysis by Age Range

„ Analysis by Sex

„ Analysis by Country

„ Analysis by Time to Onset

„ Analysis by Treatment Duration

„ Analysis by AE Duration

„ Analysis by Concomitant Medications

 

„ Lecture 11: Data Mining Exercises

„ What is Data Mining?

„ Principles of Safety Data Mining

„ Challenges in Adverse Event Databases

„ Recommended Approach: Large Company

„ Components of suggested analyses

„ Discussion of external data sources

„ Pros and cons of different external data sources

„ Data Flow Elements

„ Data Mining Fundamentals

„ Description of recommended data mining

methodologies

„

Lecture 12: Pharmacovigilance and Risk Management Process

 

„ Pharmacovigilance Process

„ Signal Detection Operational Questions

„ Signal Detection Sources

„ Signaling Process

„ 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

Organized by

Country: India.Event Categories: Seminar,Training.Industry: Beauty,Health Care.