Investigator GCP, NHMRC and Regulatory Updates 2016 – 2017

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Date(s) - 21/09/2017
7:00 am - 8:30 am

St John of God Subiaco Hospital,

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Investigator Good Clinical Practice (GCP), National Health & Medical Research Council (NHMRC) and Regulatory Updates 2016 – 2017


Presenter: Catherine May, Research Network Manager, Clinical Trials Safety & Compliance


The international medical research arena has been required to undertake significant changes in the regulatory approval of medicines, medical devices and combination therapies. Harmonisation between countries aims to facilitate use of a provisional approval pathway providing sponsors and regulatory bodies with a formal and transparent process for registration of promising new medicines and medical devices based on early clinical data.

The NHMRC and ICH GCP made significant changes to their guidelines in November 2016. Further changes relevant to the safe and ethical conduct of human research trials were made in 2017. A detailed overview of these recent changes and their relevance in clinical trial conduct will be presented at this session.

The information will ensure that when investigators are planning new, or conducting current human research trials, these can be undertaken in accordance with the current guidelines that mandate ethical, safe research conduct and that data reported and recorded is credible and accurate.

Note: requalification is required every three years for those undertaking clinical trials.


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