About the Event

Foundations Bootcamp – Devices

The Foundations Bootcamps are designed for Australian MTP start-ups and SMEs developing medicines. These bootcamps will provide practical education on incorporating regulatory and reimbursement needs for both domestic and international markets into the development plans to facilitate potential earlier market access of medical devices. The program provides access to a faculty of skilled and experienced trainers and practitioners.

• 30 Mar - Day 1: Medical device development/commercialisation cycle from concept to released product
• 31 Mar - Day 2: The regulatory landscape
• 3 Apr - Day 3: Health Technology Assessment (HTA) considerations
• 4 Apr - Day 4: Clinical development planning and implementation
• 5 Apr - Day 5. Trial design fundaments & pulling it all together

* Please note: there will be some pre-work to be completed prior to the first day

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Training venue information

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Who is eligible to attend

• Start-ups (founders),
• SMEs (leaders with responsibilities for appointing clinical trial partners and or strategic development),
• Commercialisation executives,
• Clinicians and researchers.

This course prepares you to understand the factors that impact design of clinical trials and evidence generation plans to meet the requirements of regulators and consider the payors requirements. To qualify you must be developing a therapeutic goods. Registrations are limited to three people from the same organisation. ARCS reserves the right to cancel your registration (and provide a refund) if you are not eligible to attend. Contact us at arcs@arcs.com.au if you have questions about your eligibility.

About ARCS Australia & our members

ARCS is an Australian-based professional organisation which focuses on career-long professional development for its members in the therapeutic goods sector. ARCS provides education, competency building and information sharing within communities of practice, and targeted advocacy and collaboration with a range of stakeholders.

Registration fees

Registration fees (inc. GST):
ARCS Member - $550.00
Non-Member - $550.00

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