SP6518: Post Market Monitoring And Pharmacovigilance

Date posted: 22 June 2020

Event date: 29 and 30 July 2020

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 SeerPharma course will help you understand the regulatory requirements and key elements of a system you need.

Content
  • Australian Pharmacovigilance Requirements
    • Definitions, Legislation, Scope, Reporting
  • Periodic Safety Update Reports
  • Signal Detection and Safety Profile
  • Customer Complaints
  • Recalls and Market Withdrawal
Participants

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 course will be delivered as an online virtual-classroom training session.

Sessions

Each participant will attend both half-day sessions:

 Sessions  Dates  Times
 Day 1  29th July 2020  8:30am join for 9:00am-12:30pm
 Day 2  30th July 2020  8:45am join for 9:00am-12:30pm

Times are based on Melbourne, Sydney and Brisbane; Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00

Fee and Discount
  • AUD $600 (excluding GST) per participant; introductory offer
    • A 10% discount applies for 3 or more participants from the same company

Find out more and register.

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