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.

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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.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Each participant will attend both half-day sessions:

 Sessions  Dates  Times
 Day 1  13th July 2021  8:45am join for 9:00am-12:30pm
 Day 2  14th July 2021  8:45am join for 9:00am-12:30pm

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

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

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

New Session Dates To Be Advised

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions

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Proposed Trainer

David Spaulding

David has over 30 years’ experience working for companies such as GSK, DBL (now Pfizer), Hydration Pharmaceuticals and now SeerPharma. He has been appointed in various roles such as R&D chemist, Production Manager, Logistics Manager, Sales and Marketing Manager and CEO. In his current role, David oversees SeerPharma’s Training Division, including our collaboration with the University of Technology Sydney, to offer Asia-Pacific’s sole Postgraduate course on Good Manufacturing Practice (GMP). He is a past President and current Committee Member of the PDA (Australia Chapter). David holds a Honours Degree in Chemistry from Monash University and a Graduate Diploma in Business Administration from Swinburne University of Technology.