A bold initiative to strengthen Australia’s competitive edge in global clinical research

In order to capture the opportunities from a growing global economy, Australia’s long-term prosperity depends on the ability of industry to be more innovative, productive and competitive. The clinical research industry is no exception to this widely acknowledged philosophy.

Registrations are closed.

What is CRITERIA?

As part of the strategic vision of the Federal Government’s $20 billion Medical Research Future Fund (MRFF) the Medical Technologies and Pharmaceutical (MTP) sector has been identified as one of six key Industry Growth Centres as a sector of strategic priority and investment focus. Consequently, to enhance Australia’s competitive global edge in this area, MTPConnect has been established as an industry-led not-for-profit company, driven by a strategic board of eminent industry leaders who are developing a strategic vision to secure the long-term future of the MTP sector and seize the enormous opportunities ahead. The long-term Sector Competitiveness Plan set by MTPConnect highlights opportunities and drives activities to boost productivity by increasing collaboration and commercialisation, improving management and workforce skills, optimising the regulatory environment and assisting the sector to better engage in international markets.

As part of this Federal investment program, MTPConnect has provided provisional funding to the CRITERIA program – a bold and innovative two-year ARCS Australia initiated program aimed at building a formal national internship training program to provide skilled and industry-ready participants by exposing them to companies engaged in clinical research. The project will initially deliver up to 30 interns through a program of industry-led education, mentoring and internship over a two-year period. This will result in strengthening Australia as an attractive clinical research destination and expand workforce skills in the MTP space.

Who are the CRITERIA industry members?

This pioneering project is led by ARCS Australia and includes consortium members from:

With input and support from the Federal Government’s Department of Industry, Innovation and Science, ARCS and each of the consortium members is committed to building the talent pool within the wider clinical research arena. This will unlock future commercial opportunities and position our industry to better attract and capitalise on the excellent clinical research and development undertaken in Australia.

CRITERIA CURRICULUM

The CRITERIA internship curriculum includes:

  • Overview of the Medical Technology, Biotechnology, and Pharmaceutical (MTP) sector

  • Overview of drug development

  • Applied GCP training for investigational sites and sponsor representatives E6(R2) - Full program

  • Essential and practical GCP training for new monitors and CRAs

  • NHMRC - Ethics review in Australia and the HREA

  • NHMRC - Good practice process for site assessment and authorisation phases of clinical trials research governance

  • Participant recruitment: Be proactive not reactive

  • Essential documents and good documentation practice

  • Introduction to pharmacovigilance: A theoretical approach

  • NHMRC - Guidance for safety monitoring and reporting in clinical trials involving therapeutic goods - Recent changes

  • Overview of phase I clinical trials for regulatory professionals

  • Preparing for a sponsor audit

  • Best practises of the clinical trial process from study hand-off to close out for CRAs, from client/CRO perspective

  • Essential GCP for sponsor representatives

  • Therapeutic area training