VIRTUAL WORKSHOP
Our training and education offers have been developed according to Australian and international best practice standards.
Our 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.
GCP for Medical Devices: What You Need to Know
“Yet another informative and interesting session. It gave me an excellent foundation of knowledge to further assist me in my role. I would recommend this workshop to researchers and students working in health and medical sciences with an interest in medical devices, HREC members and secretariats, and anyone involved with medical device related clinical trials. I always leave these sessions with a deeper understanding of the topic and the ways in which it will help me do my job.” – Alison Harwood, Human Research Ethics Officer, University of Adelaide
“This workshop was exactly what I needed. It reinforced and explained on things I already knew and opened my eyes to areas that I need to know more about. [The facilitator] was excellent, personable, authoritative and engaging. They provided plenty of practical examples and anecdotes from real world experience and I could see how my situation related to the GCP principles with the help of those “bridges to reality”. – Julia Wunderlich, Senior Clinical Research Fellow, Bionics Institute
Do you use medical devices in your research and/or clinical trials?
The TGA have strict regulations for medical devices. Regulations continue to evolve as advancements in technology increase the complexity of medical devices.
It’s essential that you are familiar with the latest regulations – however, keeping up to date can be overwhelming.
GCP for Medical Devices is an expert-led workshop designed to provide you with valuable guidance on how to navigate the latest regulations and standards related to medical devices. By strengthening your knowledge of the latest standards and regulations, you can ensure your research with medical devices leads to excellent science and reduced risk.
You can claim 3 CPD points on completion of the course.
Who is this workshop for?
- All staff who use medical devices in their research and/or clinical trials
- All ethics and governance staff
Learning Objectives
On completion, you will:
- Be able to distinguish between what is and isn't a medical device
- Have the most up to date understanding of laws and regulations to ensure compliance
- Ensure the medical devices in your work are safe and effective
- Identify the essential documents required to begin a medical device clinical investigation
- Define what is meant by Good Clinical Practice (GCP) with reference to ISO 14155: 2020 and the laws and guidelines that govern the conduct of research
- Understand how ISO standards 14971:2019 and 13485:2016 are relevant to ISO 14155:2020
- Have the knowledge and skills to enhance your science and data quality, and support the safety and wellbeing of research participants
About the Facilitator
Dr Mark Flynn
Dr Mark Flynn is a highly experienced MedTech clinical leader and strategist, particularly in identifying and solving the wicked challenges in healthcare.
He has launched over 20 medical devices for millions of people globally. He is a clinical strategist who is adept at R&D and new product introduction into global markets. During his career he has worked and lived in Australia, Europe, USA, China, and Latin America.
Mark has held senior executive leadership positions at Cochlear Ltd, Demant A/S, and for medtech start-ups in Europe (e.g., Wise Neuro & IQORO) and Australia (e.g., Atmo Biosciences, Hemideina Pty Ltd).
Mark was awarded a PhD in Medicine (1998) from the University of Melbourne. In 2017 he was awarded dual MBAs from Georgetown University (USA) and ESADE School of Business and Law (Spain).
He has sponsored medical device clinical trials in Europe, USA, Latin America, Asia, and Australia, often complex multicentre studies for regulatory approval/clearance ad post market follow-up.
He has developed his strategy to deliver clinical trials meeting regulatory requirements while mixing in pragmatism to deliver marketing and reimbursement outcomes at the same time.
Price
$599pp plus GST
*Savings available for group enrolments and for PRAXIS partner organisations.
Next Virtual Workshop
TBC: 10.00am – 14.00pm
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances such as low registration/attendance numbers or changes in Government restrictions surrounding the ongoing COVID19 pandemic. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions document.
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.