A04. TGO 91 compliance workshop
Tracks
Prescription and Non-Prescription Medicine Regulation
Wednesday, June 12, 2024 |
11:15 AM - 12:15 PM |
Parkside 1 |
Chair & Speakers
Mrs Shanthi Vijayakumar
Regulatory Affairs and Pharmacovigilance Manager (ANZ)
MEDISON PHARMA PTY LTD
Chair: TGO 91 compliance workshop
Abstract
The workshop would involve an interactive artwork development session for a prescription medicine. It could involve a 30 minutes briefing session and a competition involving identifying errors in an artwork
Biography
Shanthi Vijayakumar has 35 years of experience in the Australian and global pharmaceutical industry. She is deeply committed to go above and beyond in achieving excellence in her profession thereby helping to improve the lives of patients suffering from the most complex diseases.
Shanthi has a deep understanding of a wide range of therapeutics areas including oncology, cardiology, neuropsychiatry, recombinant, plasma-derived products, rare disease and, she is also currently focusing on RNAi Therapeutics. Shanthi is the Regulatory Affairs and Pharmacovigilance Manager (ANZ) at Medison Pharma Australia Pty Limited providing the oversight and management of regulatory & PV strategy and building organisational capabilities and deliverables.
As a volunteer of ARCS, Shanthi has been an active member of ARCS for many years. Over the years, Shanthi has served as Convenor of Regulatory Education, Conference Advisory Committee member, Chair/Speaker at ARCS Conferences and as a committee member in developing regulatory affairs competency framework. She also enjoys coaching and mentoring individuals to help them perform at their best.
Jacinta Watt
Director (Acting) Pharmaceutical Chemistry Variations Section, Scientific Evaluation Branch
Department of Health and Aged Care (TGA)
TGO 91 compliance workshop
Abstract
The workshop would involve an interactive artwork development session for a prescription medicine. It could involve a 30 minutes briefing session and a competition involving identifying errors in an artwork
Biography
Jacinta Watt is currently the acting Director of the Pharmaceutical Chemistry Variations Section (PCVS) of the Therapeutic Goods Administration (TGA) Since January 2023. The Section is responsible for the evaluation and approval of post-market quality changes to prescription medicines. She joined the TGA in 2008 and has worked across the TGA in the Labs Branch, Complementary and Over the Counter Medicines Branch and PCVS. She has a background in organic chemistry.
Vanessa Caig
Assistant Director, Scientific Operations Management Section, Scientific Evaluation Branch
Department of Health and Aged Care (TGA)
TGO 91 compliance workshop
Abstract
The workshop would involve an interactive artwork development session for a prescription medicine. It could involve a 30 minutes briefing session and a competition involving identifying errors in an artwork
Biography
Vanessa Caig is an Assistant Director in the Scientific Operations Management Section within the Scientific Evaluation Branch of the TGA, where she is leading medicine labelling reforms. She previously managed the TGA Names team in overseeing the ingredients database which is the repository of all Australian Approved Names for use in therapeutic goods. Vanessa joined the TGA in 2016, prior to which she worked in private industry focusing on high-throughput genomic sequencing to aid crop improvement while maintaining biodiversity.