Human Research Ethics Committee and Therapeutic Goods Administration Clinical Trials Discussion Forum

Information on the terms of reference, membership and meetings of the Human Research Ethics Committee (HREC) and Therapeutic Goods Administration (TGA) Clinical Trials Discussion Forum (the Forum).

This information is intended for HRECs interested in collaborating with the TGA.

Terms of reference

The HREC and TGA Clinical Trials Discussion Forum (the Forum) provides a mechanism for collaboration between the TGA and HRECs. It allows for informal discussion and information sharing on a range of emerging regulatory challenges and opportunities for clinical trials in Australia.

The Forum is not an advisory or policy decision-making group and is not a statutory committee of the TGA.

Participation

Participation in the discussion forum is open to all Australian HRECs to help facilitate collaboration between HRECs and the TGA.

HRECs can send different representatives to each Forum depending on the agenda topic.

Appropriate representatives from the TGA and the Office of the Gene Technology Regulator will participate.

Any Australian HREC is welcome to join the Forum by emailing clinicaltrials@health.gov.au

Meetings and communiques

The Forum is usually held 3 times a year. Following each meeting, a communique is published in the outcomes below.

Contact us

Email clinicaltrials@health.gov.au