The ISO 14155 standard provides crucial guidance and support to any key parties involved in the design, conduct, recording or reporting of a clinical investigations for medical devices – primarily to sponsors (including monitors) and investigators, but also ethics committees, regulatory authorities and notified bodies implicated in the conformity assessment of medical devices. The latest version (2020) replaces the 2011 release and brings the requirements of this standard into close alignment with ICH-GCP significant changes and improvements throughout the majority of areas on clinical research with medical devices covered within the document. This course provides not only a description of the contents of the document but a comprehensive and practical guidance on how to implement the requirements – including many examples. This virtual workshop assists you to understand the updated application of good clinical practice standards according to the internationally accepted ISO 14155 guideline and other related guidance. Come prepared to share your experience and to learn from others in attendance.
Topics covered:
The virtual classroom includes a simple online assessment
By the end of this session you will be able to:
Suzanne Williams
Suzanne has 30 years' clinical trial management experience spanning big Pharma, Medical device, large and boutique CROs. Co-founding Mobius Medical in 2008 was a highlight of Suzanne's career and fuels her passion of helping MedTech and pharma companies with their clinical trials management. Suzanne and her team now enjoy helping dozens of clients navigate the Australian and New Zealand clinical trials landscape - one rich in quality and efficiency for running all phases of research.
Upon completion of this workshop, attendees will receive 3 CPD points.
If you have any questions on your suitability for this workshop, please call the ARCS office on (02) 8905 0829.
Workshop fees (incl. GST):
Early bird - until 23 Oct
ARCS member - $420
Non-member - $625
Standard – from 24 Oct
ARCS Member - $520
Non-member - $780
Registration terms and conditions
Attendee requirements:
Computer/laptop connected to power
Good internet access (1Mbps or better – broadband recommended)
A charged mobile phone and headphones (if using your phone for audio)
Phone charger – given the event goes all day, you will need a way of charging your phone
Headphones for computer audio (if using computer audio)
A quiet room/space
Before joining, be sure to check system requirements to avoid any connection issues
"Thanks for a great session!" Senior Leader, ReSQ Clinical Research Pty Ltd.
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