PRAXIS is currently offering a series of FREE webinars, designed to support our HREC and Clinical Trials sector as they prepare to emerge from the impacts of the COVID19 pandemic. Our PRAXIS Australia webinar series is generously supported by SMGCP, MTPConnect, the NSW Health Office for Health and Medical Research, SA Health Medical Education and Training Unit and our newest sponsor, Health Translation SA. PRAXIS would like to express our most sincere thanks to these sponsors for their generous support.

Building Resilience in times of Covid-19

Review our menu of FREE webinars to help you to manage your sites, research and clinical trials, with a particular focus on resilience in the era of Covid-19.

Each session is facilitated by sector experts to ensure that the advice you are receiving is relevant and current. Together, we can find strategies to ensure our sector remains strong and that collectively we can emerge from the other side of the pandemic, strong, resilient and more competitive than ever.

Refresher GCP 2

Facilitator: Sophie Mepham, ICON

Date: Friday, 30th October, 2020        Time: 9:00am-11:00am AEST

Participation only open to NSW Health and NSW Medical Research Institute Staff. 

In conjunction with Sophie Mepham GCP, PRAXIS Australia and NSW Health OHMR, clinical trials NSW are offering sites and institutions from across NSW Health, access to this webinar: Good Clinical Practice Refresher. This webinar based training platform can be used by sites and institutions to support their staff and protect the safety and welfare of research participants. These training sessions can be accessed by your staff remotely – from home or wherever they may be.

These sessions cover the required minimum GCP Refresher elements, as articulated by TransCelerate, to provide evidence of compliance with GCP, to ensure your site and institution remain compliant with the minimum training requirements.

Certificates of attainment will be issued to all attendees after each session, upon successful completion of a short online quiz.

ISO 14155:2020 - Clinical investigation of medical devices for human subjects
Good Clinical Practice: What do you need to know.

Facilitators: Tanya Symons ( T Symons Associates) and Paul Christensen (Senior Clinical Program Manager at Medtronic)

Date: Tuesday, 22nd September, 2020        Time: 10:00 – 11:30am AEST

The third update to ISO 14155:2020 (Clinical investigation of medical devices for human subjects – Good Clinical Practice) was released in June and is valid from the time of publication, with no formal transition period. This revised standard describes how to implement Good Clinical Practice (GCP) for the design, conduct, recording and reporting of medical device clinical studies involving humans, and applies to manufacturers and clinical research professionals who work on pre and post-market clinical investigations designed to determine safety and performance of a medical device. 

The June 2020 version introduces changes that facilitate compliance to other international standards, such as ICH-GCP. The main goal of these changes is to ensure that the standard keeps its global acceptance level and that all those working on device trials are guided on the accepted requirements that drive the collection of high quality data and protect the safety and welfare of participants. Sounding familiar? 

But what are the key differences and what do you need to know? 

Join our guest facilitators, Tanya Symons (T Symons Associates) and Paul Christensen (Senior Clinical Program Manager at Medtronic), for this rapid update session, as we walk you through the standard and explore how it differs from ICH-GCP. We’ll outline the key changes incorporates in this revision and how these changes impact those working in clinical trials that involve the use of devices across various classifications. 

Great work on this. We had a starting understanding, but this helped clarify a few things and definitely like the emphasis on QMS etc.

Although it still feels like a daunting mountain of a task (I’m in a very small team), I have been inspired to start (and to …

I just wanted to say thank you, to you and Sophie for the webinar yesterday. I found it to be a great session and very …

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