Module 1 | Introduction

Introduction of Masterclass, Participants, Trainers

  • Introduction to Pharmacovigilance
    • History and development of Pharmacovigilance (PV)
    • Definitions EU and USA
    • EU and US FDA regulations
    • Introduction to Good Pharmacovigilance Practices (GVP)
    • Adverse Drug Reactions and other PV relevant information (part I)

Module 2 | Case Management / GVP VI

  • Case Management of PV relevant information
    • Adverse Drug Reactions and other PV relevant information (part II)
    • Data entry and narrative writing
    • MedDRA (Medical Dictionary for Regulatory Activities) Coding
    • Assessment (seriousness / expectedness / listedness / causality)
    • Privacy protection
    • Submission to regulators

Module 3 | Periodic Reports / GVP VII

  • Periodic Benefit Risk Evaluation Reports
    • Frequency – EURD list
    • Table of Contents
    • Tricky sections
    • Summary Tabulations
    • Submission and Assessment Reports
  • US PADERs
    • Frequency
    • Table of Contents
    • Listings

Module 4 | Signal Management / GVP IX + XV

  • Signal Management
    • Definitions and methods
    • Qualitative vs. quantitative signal detection
    • Use of Standardised MedDRA Queries (SMQs) and EVDAS (incl. EVDAS pilot)
    • Assessment and documentation
    • Safety Communication

Module 5 | Risk Management Plans / GVP V + X+ XVI

  • Risk Management Plans (EU)
    • Safety Concerns
    • Table of Contents
    • RMP Commitments
    • Additional Risk Minimisation, Additional PV Activities
    • Additional Monitoring – List
  • US REMS
    • Table of Contents
    • Differences to EU / Waivers

Module 6 | Studies / GVP VIII / GCP

  • Clinical Trials
    • Regulations (incl. Good Clinical Practice (GCP) and Clinical Trial Regulation)
    • Suspected Unexpected Serious Adverse Reactions (SUSARs)
    • Investigator’s Brochure
    • Development Safety Update Reports (DSURs)
  • Non-interventional studies and Post-Authorisation Studies
    • Definitions
    • Conduct and reporting

Module 7 | QPPV and PV System Master File / GVP I + II 

  • EU Qualified Person responsible for Pharmacovigilance (QPPV)
    • Expectations and qualifications
    • Back-up
    • Nomination
    • Local Safety Officer
  • PV System Master File (PSMF)
    • Responsibility and purpose
    • Structure
    • Key Performance Indicators (Part I)
    • Deviations / Corrective and Preventive Actions (Part I)
    • Update
    • Availability and submission – Summary of the PV System

Module 8 | PV Compliance, Audits, Inspections / GVP III + IV 

  • PV Compliance Management
    • Definitions
    • Indicators (Part II)
    • Compliance Report
  • PV Audits and PV Inspections
    • Audit universe
    • Risk-based audit algorithm
    • Preparation and conduct
    • Report and follow up / Corrective and Preventive Actions (Part II)

Module 9 | PV Agreements and PV SOPS / GVP II 

  • PV Agreements
    • Need
    • Structure / Content
    • Escalation
    • Review
  • PV SOPs
    • Overview of PV SOPs
    • Requirements and stumbling blocks
    • Monitoring and update

Module 10 | PV Risk Assessment Committee (PRAC) / Safety Issues 

  • PRAC
    • Structure
    • Responsibilities
    • Examples of current activities
  • EU Referrals / Recalls
    • Regulatory background
    • Examples
  • Conclusion of Masterclass
    • Insights and Learnings
    • What is next?
 Indietro