Tuesday, February 19
13:00 – 15:00
“Flipped” = (partial online + 2 hours Face-to-Face attendance where you will be engaged in discussion, case studies and a question and answer format).
$200 per person.
Tanya Symons (Director, T Symons Associates PTY LTD)
Tanya has established her consultancy in Australia, working for both Commonwealth and State governments. She is using her knowledge of international best practice to influence the streamlining and standardisation of research-related processes in Australia and authored the 2016 Safety Monitoring and Reporting Guidelines and its three supporting guidelines for the NHMRC. She is the GCP training provider for numerous organisations across Australia.
The session will provide an informal but intensive overview of ICH GCP – giving delegates an opportunity to develop their knowledge on a range of GCP concepts. Topics include:
The regulatory framework
The practical application of the principles of GCP
Key sponsor and investigator activities
Safety Reporting in Research
Informed Consent and Study Records
Reporting and Archiving
Anyone conducting human research who has attended a previous GCP training course but would like a ‘refresher’. The session is primarily designed for those working on drug or medical device trials; either managing their own investigator-led trials or collaborating on externally sponsored multi-centre clinical trials. Investigators working on other interventional trials will also gain useful insights into the quality systems that apply.
Fiona Stanley Hospital, South Metropolitan Health Service