The RETP presents a workshop on

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

Time: 2 hours including an online quiz for certification

Day & Date:

Thursday, February 21

Time:

13:00 – 15:00

0Weeks0Days0Hours

Workshop Format

“Flipped” = (partial online + 2 hours Face-to-Face attendance where you will be engaged in discussion, case studies and a question and answer format).

Cost

$200 per person (*please note that some institutions are hosting and funding this w/shop for their staff).

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 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

Who should attend?

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.

Location

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

Room (TBC)

REGISTER your interest here

1 + 3 = ?

20 places available

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