15 Jul | CHICC Expert Workshop: Clinical Trials Best Practice

Clinical Trials Best Practice

Clinical trials – made simple. Let’s deepen your understanding of clinical trials and build your confidence and capability to provide reliable, evidence-based solutions. High-quality evidence can be used strategically across your business – from securing customers to achieving TGA verification and becoming a thought leader in your sector. Our upcoming CHICC workshop provides you with the skills and knowledge to streamline and plan a strategic evidence strategy that maximises your impact.

You’ll learn from experienced innovators and connect with other startups in the digital health tech space.

If you need to design and deliver robust clinical trials and evidence – this workshop is for you. Don’t miss your chance to learn and connect to build a safe and successful digital health solution.

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Time:  11:00 am Workshop | 1:30 pm Lunch & Networking

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What will you learn?

• Understand the relevance and value of clinical trials – specifically in the digital health sector.
• Learn about evidence generation strategy through the lens of multiple key stakeholders, including regulatory experts, health care providers, and innovators.
• Understand how to align your clinical evidence and regulatory strategies.
• Gain practical tips from experienced innovators – utilising first-hand experience with clinical trials.
• Understand what quality evidence looks like when entering partnerships, and how to be a good trial partner.
• Share your evidence-based learnings with sector and industry peers.
• Learn about our shared initiatives with the TGA – supporting your SME to navigate regulatory guidelines and compliance requirements for Software as a Medical Device (SaMD).

Who are the speakers?

• Stefan Czyniewski, Co-Founder and Principal, Mobius
• Paul Clark, Director, Eleven Borders
• Dr. Kyle Berean, Head of Clinical Affairs, Atmo Biosciences
• Jayne Barclay, Executive Director, Digital Innovation, CIO, The Royal Victorian Eye and Ear Hospital

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‍Note: Filming and Photography may be taking place at this workshop. Some of this material may be available to you following the workshop.  

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About the Speakers

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Stefan Czyniewski, Co-Founder and Principal, Mobius

Co-Founder, Principal and Clinical Director at Mobius Medical. Stefan has extensive expertise across business development, lead generation, clinical trial design, clinical trial management, site feasibility and qualification, site initiation, monitoring, close-out, medical writing, data management, EDC development and validation, QMS and QA.

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‍Paul Clark, Director, Eleven Borders

Paul L. Clark is a seasoned veteran in the Medical Device (MedTech) industry with over 30 years of experience. He has a diverse background, having worked in various capacities such as regulatory affairs, quality management, clinical research, product development, and operations.

Throughout his career, Paul has worked for regulatory agencies in Australia, Canada, the US, and Europe, and has also worked with startups and medium-sized MedTech companies in Australia and the US. He possesses a unique skill set that combines his regulatory, quality, and clinical background with proven commercial experience, including the successful launch of MedTech products in the ANZ market.
Paul's experience spans a range of active and non-active MedTech technologies, including implantable devices, cardiovascular, ophthalmic, drug delivery, renal, gastrointestinal, surgical, intensive care, wound care, imaging, mental health, monitoring devices, Software as a Medical Device (SaMD), wearable technologies and other digital health technology.

He has direct experience working with the TGA as a medical device evaluator, has been a CE Lead Auditor with TUV SUD, worked with the Canadian Medical Devices Bureau, and has dealt directly with the FDA for over 30 years. Paul has also worked directly with a number of startup MedTech ventures both in the US and Australia, and as an independent consultant/founder of Paul L Clark and Associates and Eleven Borders Pty Ltd.

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Dr. Kyle Berean, Head of Clinical Affairs, Atmo Biosciences

Dr Kyle Berean has a PhD in materials science and electronic engineering. As an early career researcher he has >30 peer reviewed journal articles, many in prestigious journals such as Nature Electronics. Kyle has over six years of experience during his PhD and post-doctoral roles in digital health technologies through running clinical trials and developing biomedical devices. Kyle is a co-inventor of the Gas Sensing Capsule and has managed many aspects of the project including the successful completion of the phase 1 human trials, the future technology roadmap and the commercialisation pathway.    

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Jayne Barclay, Executive Director, Digital Innovation, CIO, The Royal Victorian Eye and Ear Hospital

Passionate Digital Health leader and advocate, with over 10 years’ of experience working in health information technology. Jayne has gained valuable experience from roles held in both the Private and Public sectors, with experience ranging from clinical systems implementation and software development projects to strategic and operational management of health technology portfolios.

With an increasing demand to improve outcomes, experience, and creating a sustainable healthcare system, she is a strong believer in balancing clinical and technical skills to maximize current health technologies across all healthcare settings.

Conditions: 

• CHICC workshops are free to Victorian Digital and Digitally Enabled Medical Technology Companies thanks to the support of the Australian Medtech Manufacturing Centre and the Victorian Government Department of Jobs Skills Industry and Regions.  
• All participating companies will be required to participate in post-workshop surveys as a condition of registration. Companies which do not complete post-workshop surveys may be required to pay a registration fee for any future workshops. 
• Numbers are strictly limited with only 30 seats available at each workshop. 
• ANDHealth reserves the right to allocate limited availability to maximise the number of companies that will benefit from the program.

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Workshop Agenda:

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9:00 am - Welcome - Tayla Turner, Program Director - ACTIVATE, ANDHealth

9:05 am - Introduction to clinical trials - Stefan Czyniewski, Co-Founder and Principal, Mobius

10:05 am - Aligning your evidence generation and regulatory strategies - Paul Clark, Director, Eleven Borders

11:05 - 11:15 am - Break

11:15 am - The Innovator Perspective - Kyle Berean, Head of Clinical Affairs, Atmo Biosciences

12:15 pm - The Healthcare Provider Perspective - Jayne Barclay, Executive Director, Digital Innovation/ CIO, The Royal Victorian Eye and Ear Hospital

1:15 pm - Overview: SaMD Office Hours with ANDHealth - Numa Wadhwania, Portfolio Manager, ANDHealth

1:30 pm - Close and Networking

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NOTE: If you are interested in participating in this workshop but have not attended past ANDHealth events or programs within the last three months, you are required to fill out the following engagement form: https://airtable.com/appyTjaf7... ‍

Conditions:

• This workshop is highly subsidised for Victorian Digital and Digitally Enabled Medical Technology Companies thanks to the support of the Australian Medtech Manufacturing Centre and the Victorian Government Department of Jobs Skills Industry and Regions.
• All participating companies will be required to participate in post-workshop surveys as a condition of registration. Companies which do not complete post-workshop surveys may be required to pay a registration fee for any future workshops.
• Numbers are strictly limited with only 30 seats available at each workshop.
• ANDHealth reserves the right to allocate limited availability to maximise the number of companies that will benefit from the program.