The RETP presents a workshop on

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

Day & Date:

Wednesday, February 20

Time:

13:00 – 16:00

0Weeks0Days0Hours

Workshop Format

“Flipped” = (partial online + 3 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 outline

This course provides HREC members with an informal but intensive overview of the fundamentals of clinical research including the demystification of commonly used trial jargon. It introduces some of the relevant concepts from the Good Clinical Practice Guidelines, clarifies the roles and responsibilities of key players and explores ethical concepts associated with key trial activities such as informed consent, safety reporting and trial reporting.

Who should attend?

Any member, or potential member of an ethics committee who would like a better understanding of the specific ethical issues that apply to clinical trials, particularly those involving drugs or medical devices.

Location

Curtin University

The WAHTN, Clinical Trials & Data Management Centre

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