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