Dates:
Dec 03-04
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A 2-day practical & interactive training:

A practical guide
to Pharmacovigilance

This two-day course focuses on topics essential to effective pharmacovigilance, including sessions to strengthen the WHO Programme for International Drug Monitoring, e.g. pharmacovigilance best practices, communications, creating a reporting culture and pharmacovigilance tools.

Overview

An increase in drug safety concerns and Adverse Drug Reactions (ADRs) reported in recent years, along with some high-profile drug withdrawals have led to the need for proactive pharmacovigilance. This has also resulted in an increase in the volume of data handled and a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal.
It has been a constant challenge to standardise pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geographical, cultural and medical practices in this region. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance.
This two-day course focuses on topics essential to effective pharmacovigilance, including sessions to strengthen the WHO Programme for International Drug Monitoring, e.g. pharmacovigilance best practices, communications, creating a reporting culture and pharmacovigilance tools.
The course agenda also includes hands-on signal detection and causality. Training, built around lectures and practical exercises, takes place in an open and interactive environment. Plenty of opportunities to interact with faculty experts and fellow course participants.

Key Learning Outcomes

  • The role of drug safety in the successful development and usage of a medicine to the benefit of patients
  • What safety-related questions need to be answered in early and late drug development
  • Tools, techniques, and methodologies used in drug safety evaluation
  • What frequent pitfalls related to drug safety considerations occur and why they can lead to discontinuation of drugs in development, label changes or even withdrawal of drugs from the market after launch
  • How changes in safety assessment could become part of a new drug development paradigm

Who should attend

  • Anyone responsible for Pharmacovigilance
  • CEOs, Directors, Heads of Departments, Managers of:
    • International Pharmacovigilance
    • Clinical managers
    • Medical and Regulatory Affairs
    Very Hands-On and Interactive:

    Case study – setting up a system for pre- and postmarket Pharmacovigilance
    Case study – Exploring responsibilities for the QPPV
    Case study – Global Pharmacovigilance activities
    Case study – Signal detection and risk assessment
    This course is a cooperation with IBC Asia - Singapore’s leading conference, exhibition and training company.
    EARLY BIRD RATE: Register and Pay on or before 29 September 2018:
    SGD 3.295 (SAVE SGD 200) / EUR 2.063,99 / USD 2.420,11
    NORMAL RATE: Register and Pay after 29 September 2018:
    SGD 3.495 / EUR 2.189,27 / USD 2.567,01
Book this training
Book now (PDF with booking formular)
For further questions please contact us:
Michor Consulting: +43 (0)1 890 57 14 | office@michor-consulting.eu
IBC Asia: +65 6508 2401 | register@ibcasia.com.sg
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