SPECIAL OFFER
Life Sciences Queensland: An Exclusive Offer for LSQ Members!
LSQ is proud to partner with PRAXIS Australia to offer ONE FREE place in a highly rated Workshop (valued at $599 + GST)!
TO APPLY, PLEASE CONTACT LSQ DIRECTLY VIA:
Natalie Davis
Engagement & Partnerships Manager
Life Sciences Queensland Limited
EMAIL: ndavis@lsq.com.au
(DO NOT ENROL DIRECTLY)
ABOUT THIS WORKSHOP
Date: 19 June | Time: 10am – 4pm (AEST)
Facilitator: Sarah Piplica, UniSC Clinical Trials Centre
CPD Points: 4
- ICH E6 (R3) Guideline updates (endorsed Jan 2025)
- GCP principles and legal frameworks
- Roles and responsibilities in clinical research
- Essential documents and informed consent
Safety reporting and data quality
You can also claim 4 CPD points on completion of the workshop!
What will you learn?
On completion, you will be able to:
- Define what is meant by Good Clinical Practice and the laws and guidelines that govern the conduct of research, so you remain compliant
- Understand the roles and responsibilities of everyone involved in research, so you are able to achieve greater collaboration and success
- Demonstrate an understanding of essential documents, enabling you to achieve consistency, efficiency and standardization
- Describe the process of informed consent and what is meant by vulnerable groups, so you can complete the process confidently and efficiently
- Demonstrate an understanding of clinical trial drug management, safety reporting and safety reporting terms
- Define the importance of data collection and case report form completion and be able to identify the risks associated with poor data collection and research misconduct
- Understand the impending changes in the R3 update, which include an emphasis on quality and proportionality, and reflect the growth of novel trial designs and technology.
Sarah is the Regulatory, Startup and Patient Partnerships Manager at University of the Sunshine Coast (UniSC) Clinical Trials Centre in Queensland. In her role, Sarah provides high level strategic advice and guidance in the overall management and compliance of extensive and complex ethics and regulatory processes, maintaining quality standards and monitoring and audit readiness.
In 2019, Sarah was awarded the Osmond Russell Scholarship from ARCS, for a project that is seeing her research and validate a patient co-authored survey to solicit regular and meaningful feedback from clinical trials participants. Sarah is passionate about advocating for patient, participant and carer involvement within the medicines development industries.
PRAXIS training and education offers have been developed according to Australian and international best practice standards.
PRAXIS modules are built upon the competencies developed by the Harvard Multi-Regional Trials Centre (MRCT) and aligned to competencies recommended by the NHMRC.
These training offers are regarded as a benchmark for researchers, clinical trials, and healthcare professionals in Australia and internationally.
