B19b. Relevance of ISO 9001:2015 for pharmacovigilance systems
Tracks
Pharmacovigilance
| Wednesday, June 4, 2025 |
| 3:15 PM - 3:45 PM |
| Parkside 1 |
Chair & Speakers
Dr Jason Woods
Senior Pharmacovigilance Specialist
Cencora PharmaLex
Relevance of the international Quality Management Systems Standard ISO 9001 for pharmacovigilance systems
Abstract
An increasing industry expectation is that medicine sponsors and their vendors maintain a Quality Management System (QMS) that complies with the international Standard for QMS, ISO 9001. In a Quality Management context, pharmacovigilance (PV) systems can be described as an organisational requirement supported by the QMS of the organisation. This session will cover the requirements of ISO 9001:2015 that are relevant to PV systems, advantages of PV systems supported by a QMS compliant with ISO 9001:2015, and how organisations can demonstrate compliance with ISO 9001:2015. This session is aimed at PV professionals, those with an interest/background in PV and/or interact with PV systems, and those with accountability for the performance of PV systems, that want to learn about QMS and/or ISO 9001:2015 in a PV context.
Biography
Jason Woods is a Senior Pharmacovigilance Specialist at Cencora PharmaLex. Jason has a background in medical research, where he investigated environmental impacts on Alzheimer's disease risk. Recognised for academic excellence, Jason is a Dunkley and University Medallist and has been awarded several academic prizes, emphasising his commitment to advancing knowledge and innovation.
Following completion of his PhD, Jason joined a small consulting firm where he launched his career in pharmacovigilance consulting. Today, through his work at Cencora PharmaLex, Jason provides local pharmacovigilance services and advice to therapeutic goods sponsors in Australia and New Zealand to help them meet their pharmacovigilance regulatory obligations and ensure patient safety. Jason continues to be passionate about the field of pharmacovigilance and transforming it beyond a compliance function in order to continually improve patient safety.
Jason will share insights into the critical intersection of pharmacovigilance and Quality Management Systems, drawing on his pharmacovigilance consulting experience to explore the advantages of ISO 9001:2015 compliance for pharmacovigilance systems.
