B08. RMP and RMMs - it takes a village

Tracks
Pharmacovigilance
Thursday, June 13, 2024
11:15 AM - 12:15 PM
Parkside 1

Chair & Speakers

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Mr Duncan Maher
Patient Safety Manager
Commercial Eyes

Chair: RMP and RMMs - it takes a village

Abstract

Walk through the complexities of the RMP/RMM space with the roles of key stakeholders, Reg, Medical and PV from different companies to talk through the application of the RMP guidelines.

- Australian specific lens
- Expansion of PV oversight requirements
- Patient-centric expectations for educational materials

Biography

Duncan has been working in PV in Australia, with a decade of experience for sponsors and as a consultant, working across clinical trials, post market pharmacovigilance and medical affairs, as well as in the risk management planning and implementation space. Duncan is currently working as a LPPV in Australia and New Zealand for several sponsor companies with a presence in these territories, and has a passion for education and advocacy around all things patient safety.
Agenda Item Image
Mr Duncan Maher
Patient Safety Manager
Commercial Eyes

RMP and RMMs - it takes a village

Biography

Duncan has been working in PV in Australia, with a decade of experience for sponsors and as a consultant, working across clinical trials, post market pharmacovigilance and medical affairs, as well as in the risk management planning and implementation space. Duncan is currently working as a LPPV in Australia and New Zealand for several sponsor companies with a presence in these territories, and has a passion for education and advocacy around all things patient safety.
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Louise Davis
ANZ Pharmacovigilance Manager
Abbvie Pty Ltd

RMP and RMMs - it takes a village

Biography

Louise Davis currently holds the position of PV Manager & Affiliate Safety Representative at AbbVie. Louise has over 18 years’ experience in the Pharmaceutical Industry predominantly in Pharmacovigilance. She has gained experience in other functional areas including Patient Experience, Medical Information and Clinical Trial Management. Louise has previously worked at Eli Lilly and Merck Serono before moving to AbbVie where she has been for the past almost 9 years. Louise obtained her Nursing degree from the University of Sydney, obtained a Critical Care certificate, and has worked in Children’s Hospitals in both Sydney and London in the Paediatric Intensive Care environment. Louise is dedicated to ensuring the company meets its compliance and PV requirements and elevating the PV brand. Louise is very passionate about building strong professional relationships and with her extensive experience in managing teams is dedicated to helping her team’s development so they can reach their full potential. Louise is also one of AbbVie’ s Innovation Facilitators, where she coach’s AbbVie employees on the skills, behaviours and processes that are integral to making innovation a daily, routine activity.
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Kate Hamilton
Medical Manager
Sandoz

RMP and RMMs - it takes a village

Biography

Kate is a Medical Manager at Sandoz where she has worked for the past two years. Kate has over 15 years’ experience in Medical Affairs in the pharmaceutical industry in highly collaborative roles, working closely with Regulatory Affairs, Marketing & Commercial, Customer Service, Pharmacovigilance, Clinical and QA departments. Kate also worked for five years as Project Coordinator at Westmead Hospital managing multiple Investigator Initiated projects.
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Iga Policinska
Principal Evaluator, Pharmacovigilance Branch
Department of Health and Aged Care (TGA)

RMP and RMMs - it takes a village

Biography

Dr Iga Policinska is the Principal Evaluator and team lead of the Risk Management Plan Team 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 represented the TGA internationally through aid programs.
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