The RETP presents a workshop on

ICH Good Clinical Practice (GCP) E6 (R2) and regulatory requirements for Clinical Trials

3.5 hrs

Catering: A light morning tea provided

Day & Date:

Monday, February 18

Time:

09:00 – 12:00

0Weeks0Days0Hours

Workshop Format

“Flipped” = Face-to-face (3hrs) + some online component (30 min).

Cost

$200 per person.

Facilitator

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.

Course topic overview

The origins of GCP

Good Clinical Practice and the Regulatory Framework

The Conditions and Principles of GCP

Reporting and Archiving

Sponsor and Investigator Activities

Safety Reporting in Research

Informed Consent  and Study Records

Who should attend?

Anyone conducting human research. 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.

Location

Harry Perkins Institute for Medical Research (north) at the QEII Medical Centre, Nedlands

Room (TBC)

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