B09. TGA Clinical Trial Landscape Updates
Tracks
Clinical Research Landscape
Thursday, June 13, 2024 |
1:30 PM - 2:30 PM |
Parkside 1 |
Chair & Speakers
Rob Kent
Research Operations Manager and ARCS Board member
The Kinghorn Cancer Centre
Chair: TGA Clinical Trial Landscape Updates
Abstract
The Therapeutic Goods Administration (TGA) has been actively investing in clinical trials initiatives - to protect the rights and safety of clinical trial participants, ensure quality data and increase regulatory efficiency. This session will update on TGA’s reforms to clinical trial processes, including the new Clinical Trial Safety reporting form. It will also focus on the Good Clinical Practice (GCP) Inspection Program, which now includes medical devices, and the GCP education outreach initiatives.
Biography
Robert is responsible for building site capabilities and the rapid expansion of the centres Phase I unit as part of the NSW NECTA collaboration. He currently manages a large portfolio Phase I – III Industry trials, as well as developing and managing multi-centred national & international Investigator led research.
Robert has been an active volunteer for ARCS since 2005 and a Human Research Ethics Committee member since 2015. Robert was elected to the ARCS board and brings a focus on site and regulatory issues to add to the representation of ARCS diverse membership.
Tahli Fenner
Director, Risk Management Section, Pharmacovigilance Branch
Department of Health and Aged Care (TGA)
TGA Clinical Trials Initiatives
Biography
Dr Tahli Fenner is the Director of the Pharmacovigilance, Compliance and Clinical Trials Section, within the Pharmacovigilance Branch of the TGA, which is responsible for managing the clinical trial notification and approval schemes, as well as the pharmacovigilance and Good Clinical Practice inspection programs. Dr Fenner joined the TGA after completing her PhD in synthetic organic chemistry. She has worked across many different areas within the TGA and the Department of Health, since starting out in medicines evaluation. Other roles within the TGA have included leading the teams responsible for developing regulatory guidance, managing medicines scheduling and expert advisory committees.
Maddy Brocklehurst
Anz Clinical Study Unit Head
Sanofi
TransCelerate
Biography
Maddy has been an active member of the TransCelerate community for many years and became the Australian chapters co-lead in 2023.
Maddy began her career in the pharmaceutical industry over 30 years ago at Ciba-Geigy in the UK, holding a variety of roles in pre-clinical and clinical operations. A brief transitional role in the oil industry as a toxicologist/eco-toxicologist with British Petroleum led to a few years in Spain before finding herself in Australia. With clinical research experience in CROs and Pharma, for the last 14 years Maddy has worked for Sanofi, seven of which were as Regional Trial Manager for Asia Pacific, Europe, Middle East, and Africa (APEMEA). The regional role across several countries offered unique opportunities to work across diverse cultures managing clinical research project.
Maddy is currently focused on ANZ with an emphasis on Project and People Management through her role as the Clinical Study Unit Head at Sanofi