The Arab Pharmacovigilance Guidelines 2019

  • 21-22 October 2019
  • London, United Kingdom

The Arab Pharmacovigilance Guidelines 2019 is a conference that covers topics such as:

  • Quality management systems
    • Quality management of PV systems
    • Quality control, quality assurance, and quality management
    • Quality and training
    • The QP PV and quality management
    • QA and quality management and internal audits
  • An Introduction to the new PV Structure
    • The interaction of the modules A comparison to the EU modules
    • The new modules
  • Pharmacovigilance inspections
    • Types of inspection
    • The purpose of the inspection
    • Re-inspections
    • Inspection ndings
  • The Pharmacovigilance Systems Master File
    • The QP PV and the PV master le
    • Licence submissions and the PV master le
    • Control/management of the PV master le
  • Risk Management Plans
    • The RMP purpose
    • ICH E2E - pharmacovigilance planning
    • Updating the RMP
    • The RMP format
    • RMPs and REMs
  • Pharmacovigilance audits
    • Audit scheduling and risk
    • The purpose of company audits
    • Audit findings and their corrections - root cause analysis, corrective action plans, completion and re-audits
    • Audit outputs and ndings
  • PSURs2
    • Objectives of the PSURs
    • ICH E2F and ICH E2C (R2) - DSRRs and PSURs/PBRERs
    • The format of the PSUR
    • Risk benefit analyses in PSURs
    • Mapping Signals and Risks to the PSUR
  • Adverse Reaction Reporting
    • Special situations
    • De nitions
    • Expectedness and causality
    • Triage - seriousness
    • Electronic ADR reporting local and International
    • Expedited reporting
    • ICH E2D - post marketing safety
    • Follow up of cases
    • Case closure
    • Literature ADR reporting
  • Signals and their management
    • Signal validation
    • What is a signal?
    • Signal assessment
    • Signal analysis and prioritisation
    • Actions to be taken

The Arab Pharmacovigilance Guidelines 2019 brings together Anyone involved in pharmacovigilance and regulatory activities including:

  • Local QP PVs
  • Pharmacovigilance case processing
  • Drug safety managers
  • Medical directors
  • PSUR writers
  • QA auditing
  • Any company managers and licence holders

The Arab Pharmacovigilance Guidelines 2019 will be held in London, United Kingdom on 21-22 October 2019.

Venue

London,
United Kingdom
  View all Hotels near Venue
Booking.com
1499 Pound Sterling
Management Forum
Rentalcars Savings

Past and Future Events

  • The Arab Pharmacovigilance Guidelines 2020 - Oct 2020 (70909)
  • The Arab Pharmacovigilance Guidelines 2019 - 21-22 Oct 2019, London, United Kingdom (75608)
  • The New Arab Pharmacovigilance Guidelines 2018 - 22-23 Oct 2018, Dubai, United Arab Emirates (75607)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.