Understand the updated application of good clinical practice standards
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 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:
Alison Horsnell
Alison Horsnell has over 25 years’ experience in clinical research in a wide range of operational perspectives including pharma, biotech, CRO, Sponsor and most recently medical devices. In her current role at an international medical device company she is responsible for the development and maintenance of standard operating procedures that comply with ISO 14155 Good Clinical Practice standards, and the implementation of technology to facilitate efficiency, consistency and transparency in clinical investigations globally.
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 7 Mar
ARCS Member - $295.00
Retired/Student Member - $225.00
Non-member - $480.00
Standard – from 8 Mar
ARCS Member - $385.00
Retired/Student Member - $295.00
Non Member - $615.00
Registration terms and conditions
Please note that virtual workshops at ARCS cover the same content as the physical (face-to-face) workshop. The training material, exercises and student workbook have been redesigned to ensure that the same learning outcomes are achieved as traditional workshops.
The registration fees for virtual workshops have been reduced to reflect the reduction in venue and catering costs associated with a face-to-face workshop. If you have any questions, please contact us at arcs@arcs.com.au.
This workshop runs from 13:00-16:00
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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