Customer complaints and adverse events/reactions relating to your products present a serious threat to your business’ reputation and financial position. All information concerning potentially defective products and/or adverse events/reactions must be carefully reviewed. Critically, you need a system to promptly and effectively recall products known or suspected to be defective from the market.
This course will help you understand the regulatory requirements and key elements of a system you need.
- Australian Pharmacovigilance Requirements
- Definitions, Legislation, Scope, Reporting
- Periodic Safety Update Reports
- Signal Detection and Safety Profile
- Customer Complaints
- Recalls and Market Withdrawal
This course will benefit you if you are the sponsor of a regulated product or responsible for any processes or personnel relating to post market monitoring or investigations including pharmacovigilance, complaints, recall, scientific and medical literature reviews, reporting, risk assessment/management and risk/benefit safety profiling.
Format and Course Length:
The 1-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Scheduled sessions run from 9am to 5pm unless otherwise specified.
Call us or click here to e-mail us and register your interest.