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Thu, 21 Mar

|

Callaghan Innovation

HTA Clinical Investigation Process for Medical Devices

This workshop aims to provide you with an overview of the clinical investigation process and an understanding of medical device company responsibilities as sponsor, enabling informed business planning and effective engagement with service providers.

HTA Clinical Investigation Process for Medical Devices
HTA Clinical Investigation Process for Medical Devices

Time & Location

21 Mar 2024, 9:30 am – 3:30 pm

Callaghan Innovation, 1 Watt Street, Parnell, Auckland 1052, New Zealand

About the event

The HealthTech Activator’s (HTA) new clinical validation workshop, Clinical Investigation Process for Medical Devices, will take place in Auckland on 21 March 2024. This workshop aims to provide you with an overview of the clinical investigation process and an understanding of medical device company responsibilities as sponsor, enabling informed business planning and effective engagement with service providers. This workshop will cover the following:

  • Introduction to the clinical investigation process and planning
  • Overview of key standards, regulations, and compliance requirements
  • Sponsor responsibilities and key aspects of clinical investigation design
  • Clinical investigation start-up activities and requirements, including the NZ ethics and regulatory landscape
  • Conducting and closing a clinical trial, including data quality, risk, and operational oversight

Who is this workshop for? This workshop is for medical device companies that need clinical data to support market access. Learn and engage with experts. The workshop is run by Julie Jones and Ruth Lucas from BioValeo. Julie and Ruth hold over 20 years of experience in clinical research covering various therapeutic areas, investigational products, devices, and all trial phases.

Event details:

  • Workshop: Thursday 21 March 2024, 9:30am-3:30pm. Lunch and tea included
  • Hosted in-person at Callaghan Innovation, Auckland
  • Cost: $195 (incl. GST and booking fee)
  • Attendance is limited to two attendees per company

To confirm your place please register no later than 14 March 2024. Spaces are limited, and a waitlist will open once the workshop is fully subscribed.

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