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