B19a. Navigating the pharmacovigilance requirements of listed and complementary medicines in the Australian regulatory environment
Tracks
Pharmacovigilance
| Wednesday, June 4, 2025 |
| 2:45 PM - 3:45 PM |
| Parkside 1 |
Chair & Speakers
Dr Iga Policinska
Director, Pharmacovigilance Compliance and Clinical Trial section,
Therapeutic Goods Administration, Australian Government, Department of Health, Disabiity and Ageing
Navigating the pharmacovigilance requirements of listed and complementary medicines in the Australian regulatory environment
Abstract
This session will focus on common findings from the TGA’s Pharmacovigilance Inspection Program (PVIP) for listed and complementary medicines, it will further explore the post-market surveillance requirements and maintaining compliance of medicines that only contain low risk ingredients.
Biography
Dr Iga Policinska is the Director of the Pharmacovigilance Compliance and Clinical Trials Section situated in the Pharmacovigilance Branch. She holds a Medical Degree and a Master of Public Health. She has previously worked internationally in a clinical setting and since joining the TGA, in 2015, she has worked across the entire regulatory life cycle of medicines. Dr Policinska holds extensive regulatory and technical knowledge ranging from clinical trials through to pre-market and post-market. She has also represents the TGA internationally through aid programs.
