In our final part of this 3 part series on Regulatory Affairs in Complementary Medicine, we welcome back Sue Woldt, Senior Regulatory Affair Manager at Integria Healthcare.

In Part 3 of this series will cover Adverse Reactions and Pharmacovigilance and your responsibilities as a practitioner. 

Sue discusses: 

• Definition of Pharmacovigilance (PV)
• What is the difference between an adverse reaction and adverse event
• Who is responsible for reporting adverse reactions and events
• Reporting an adverse reaction
• Wider implications- labelling and warnings

Quick Links:

• https://www.tga.gov.au/reporting-adverse-events