A11. TGO 92 compliance workshop

Tracks
Prescription and Non-Prescription Medicine Regulation
Wednesday, June 12, 2024
1:30 PM - 2:30 PM
Parkside 1

Chair & Speakers

Agenda Item Image
Dr Elaine Blair
Director of Regulatory Affairs APAC
PTC Therapeutics

Chair: TGO 92 compliance workshop

Biography

Elaine Blair has over 25 years' experience in the pharmaceutical industry, with extensive knowledge in a wide range of therapeutics areas including oncology, rare diseases and gene therapy. Elaine is currently Director of Regulatory Affairs APAC at PTC Therapeutics and is responsible for regulatory matters and strategies for countries in the APAC region. PTC is a global biopharmaceutical company that delivers therapies for people living with rare diseases. Elaine holds a PhD in Pharmaceutics from the University of Sydney. She is passionate about supporting regulatory affairs and education and has been an active member of ARCS since 1999. Over the years, she has served as convenor of the regulatory education sub-committee, conference advisory committee member, and as a Chair/Speaker at ARCS conferences.
Agenda Item Image
Vanessa Caig
Assistant Director, Scientific Operations Management Section, Scientific Evaluation Branch
Department of Health and Aged Care (TGA)

TGO 92 compliance workshop

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.
Agenda Item Image
Leila Shourabi
Compliance Evaluator officer, Complementary and Over-the-Counter Medicines Branch
TGA

TGO 92 compliance workshop

Biography

Leila Ranjbar Shourabi is a Scientific Compliance Evaluator in the Listing Compliance Section within the Complementary and OTC Medicines Branch (COMB) of the Therapeutic Goods Administration (TGA). The Listing Compliance Section are responsible for ensuring the quality, safety and efficacy of listed medicines through post-market compliance and enforcement activities. Leila joined the TGA in 2020 and in addition to the COMB has previously worked at the Laboratories Branch. Leila holds a PhD in Analytical Chemistry from the University of Tasmania and prior to joining the TGA, she has worked in various technical and management positions across research, education and industry sectors.
Agenda Item Image
Julie Varghese
Senior Evaluator, OTC Medicines Evaluation Section, Complementary and Over-the-Counter Medicines Branch
TGA

TGO 92 compliance workshop

Biography

Julie Varghese is a Senior Evaluator in the Medicines Regulation Division at the TGA with over 10 years experience in the OTC Medicines Evaluation Section undertaking pre-market evaluation of registered non-prescription medicines. Julie is also a registered pharmacist with a PhD in Clinical Pharmacokinetics and has previous experience as a hospital pharmacist, clinical researcher and sessional academic teaching drug formulation science.
loading