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Join us at the 2025 ARCS PV Summit on 27 March at the Adelaide Convention Centre for a unique opportunity to engage in hands-on, practical learning tailored for all those involved in Pharmacovigilance and supporting/contributing functions.
The day begins with the Qualified Persons for Pharmacovigilance (QPPV) Forum in the early morning. This is an hour long session designed exclusively for QPPVs and professionals in related roles (eg. Deputy QPPV and Australian PV contact person). This forum provides a dedicated space for in-depth discussions on the responsibilities, challenges, and regulatory expectations of QPPVs. It serves as a valuable opportunity to share insights, discuss emerging trends, and address specific issues faced by PV leaders in their daily practice.
The Pharmacovigilance (PV) Summit, themed PV Inspections and Compliance includes PV Inspection Program (PVIP) Reforms and Common Deficiencies, then commences for the broader sector. Developed and delivered in collaboration withTherapeutic Goods Administration (TGA) subject matter experts, this Summit is highly relevant not only for those working in PV but also for professionals working within related areas, including but not limited to Medical Affairs, Quality, Clinical, Regulatory Affairs, Legal, Service Providers and Medical Information, all of which are increasingly involved in contributing to PV processes, compliance and inspection outcomes. Together, ARCS and TGA are committed to providing in-depth exploration of PV processes, inspection challenges, and compliance strategies through interactive sessions. Attendees will have the rare opportunity to work directly with TGA subject matter experts in a collaborative setting, diving into real-world applications and best practices.
This summit promises to be a valuable experience for anyone seeking to stay at the forefront of PV practices and engage directly with Australia’s regulatory authority in a practical, collaborative setting. For those who are in town the night before the summit, join us for networking at the Playford Adelaide.
Agenda topics and format (subject to change):
Theme: PV Inspections and Compliance
Register Now Spots are running out fast.
Pricing AUD and inclusive of GST:
ARCS Member Standard registration (after 11-Feb-2025): $700
Non-member registration: $1200
Note: Become an ARCS member now to enjoy membership benefits including unlocking early bird rates, discounted event prices, complimentary Interest Area webinars, networking and more!
Accommodation suggestions: Playford or Intercontinental Adelaide
Speakers
Dr Iga Policinska - Director, Pharmacovigilance Compliance and Clinical Trial section, Pharmacovigilance Branch, TGA
Amanda Chan - Senior PV inspector, Pharmacovigilance Compliance and Clinical Trial section, Pharmacovigilance Branch, TGA
Dr Kasia Hoffler - Founder GXP Compliance Australia and former TGA PV and GCP Inspector
• Kasia is an overseas qualified physician and clinical auditor, specialising in GCP and GVP (PV) Quality Assurance.
• Prior to establishment of the GXP Compliance Australia, Kasia delivered TGA PV and GCP Inspection Programs, acted as a Deputy Qualified Person for Pharmacovigilance in Australia (QPPV-A) for a pharmaceutical company, executed GCP Audit Programs in Asia, and set up a CRO Site Start-up Team, managing ethics & regulatory submissions of the clinical trials in Asia Pacific region.
• Kasia is a professional member of the Research Quality Association (RQA) in the UK and ARCS in Australia.
Tristan Dimmock - Senior Associate at Norton Rose Fulbright Australia (NRFA)
• Tristan is a Senior Associate at Norton Rose Fulbright Australia (NRFA) specialising in therapeutic goods regulation, risk advisory, regulatory investigations, and compliance.
• Prior to NRFA, Tristan worked at the Therapeutic Goods Administration (TGA) in litigation, compliance, and enforcement, and was a trusted advisor to Senior Executives on complex and sensitive regulatory matters.
• In the second half of 2024, Tristan completed his post-graduate legal studies at Georgetown University in Washington DC, USA concentrating on pharmaceutical law and regulatory compliance.
Theo Giannou, Director (Founder), Bloom Agents
With over 30 years in the pharmaceutical industry, Theo Giannou has dedicated his career to advancing pharmacovigilance (PV) and drug safety. He has held leadership roles at local, regional, and global levels, shaping PV strategies across multiple pharmaceutical companies and consultancy teams.
As the former Asia-Pacific PV Head at Baxter and Johnson & Johnson, Theo played a pivotal role in building and strengthening PV capabilities across pharmaceutical, consumer health, and medical device sectors. His efforts went beyond advancing industry standards but actively contributing to the evolution of PV regulations and safety standards in the Asia-Pacific region. Based in Sydney and Shanghai, he worked closely with regulators and industry leaders to drive the adoption of best practices in patient safety.
In the past seven years, Theo has focused on consulting, guiding global clients in establishing robust PV systems and frameworks. He also founded Bloom Agents, a premier PV services company in Asia-Pacific, which now has over 50 local agents providing specialized PV expertise and services across the region.
Theo holds a Bachelor of Science in Pharmacology and Biochemistry from the University of Sydney and a Master of Medical Science in Drug Development from the University of New South Wales. In addition to his scientific expertise, he is a certified executive coach, combining his knowledge of pharmacovigilance with leadership development to support teams and individuals in achieving excellence.
Overview
Why comply? Join a conversation between an auditor and a lawyer about regulatory and legal implications of non-compliance with Australian pharmacovigilance regulations.
Dr Kasia Hoffler (GXP Compliance) and Tristan Dimmock (Norton Rose Fulbright Australia) will provide their perspectives as an auditor and lawyer and facilitate a question-and-answer session on the following topics:
ARCS would like to thank the TGA, our speakers and ARCS PV Summit commitee Caroline Benyamin, Shanthi Vijayakumar, Bianca Joo and Lorenza Ricacho and exhibitors for their participation and support in this event.
Please review the summit prospectus and contact emacmahon@arcs.com.au for further details on sponsorship and exhibition.
Exhibitors
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