• Understanding [the FDA's] 510K for [Medical] Devices [Sydney]

    The Entrepreneurs' Programme brings together two experts in the field that will be able to assist SMEs to understand from a regulatory and operational perspective what is required to ensure FDA - 510(K) compliance. This workshop will be valuable to both companies that have this accreditation but also those making the transition and aspire to operate in the medical devices sector. Presenters Andrew Batty - Lincoln Consulting Group Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has experience managing regulatory teams and external consultants to facilitate local and international device distribution. Arthur Brandwood - Brandwood Biomedical Brandwood Biomedical is an international medical device and IVD regulatory consultancy, with deep knowledge and experience of US FDA processes including successful traditional and de novo 510(k) submissions and preconsultation interactions with FDA – both remote and face to face. Founder and Principal Consultant Arthur Brandwood has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments in both start up companies and university applied research, has held senior roles including Director of Device Registrations at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/understanding-510k-for-devices-registration-44819465227

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  • IT in healthcare - getting your product to market [Regulatory Compliance & IP]

    IT in healthcare applications, devices and systems has seen rapid growth and expansion in recent times. The activities in this sector will only expand over time and companies (SMEs) and researchers should be aware, knowledgeable and prepared for these changes. Join this free workshop to hear from three experts in the field from an operational, intellectual property and regulatory perspective to assist you in getting your product to market. Expert Panel Lusia Guthrie With over 35 years in the pharmaceutical and bioscience industries, Lusia Guthri is an experienced CEO and medtech entrepreneur. She has a passion and proven track record in bringing innovative products to global markets, embracing the entire process from company formation, capital raising and concept development to product launch. She has particular experience and ongoing interest in the development and commercialisation of new healthcare products that embrace automation, robotics, machine learning and artificial intelligence. Rob McInnes Rob McInnes is a lawyer with a technical background in the life sciences, who has practices for more than 25 years in the commercialisation of IP and technology. He is ranked in the top tier of Australian IP commercialisation lawyers, and holds the US-based Certified Licensing Professional accreditation. Rob assists research organisations, start-ups, established businesses and investors with the capture, protection, management and licensing of IP rights. Terry Walsh Terry Walsh has over 15 years' experience with the regulated space spanning biotech, pharma, blood products and mecial devices. Walsh has started, run and led three businesses over the last decade in Australia to support the regulated industry in aspects of engineering, IT, quality and regulatory compliance. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/it-in-healthcare-getting-your-product-to-market-registration-45366992897 - be sure to select the Sydney Event.

  • Understanding [the FDAs] 510K for [Medical] Devices [Brisbane]

    The Entrepreneurs' Programme brings together two experts in the field that will be able to assist SMEs to understand from a regulatory and operational perspective what is required to ensure FDA - 510(K) compliance. This workshop will be valuable to both companies that have this accreditation but also those making the transition and aspire to operate in the medical devices sector. Presenters Andrew Batty - Lincoln Consulting Group Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has experience managing regulatory teams and external consultants to facilitate local and international device distribution. Arthur Brandwood - Brandwood Biomedical Brandwood Biomedical is an international medical device and IVD regulatory consultancy, with deep knowledge and experience of US FDA processes including successful traditional and de novo 510(k) submissions and preconsultation interactions with FDA – both remote and face to face. Founder and Principal Consultant Arthur Brandwood has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments in both start up companies and university applied research, has held senior roles including Director of Device Registrations at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/understanding-510k-for-devices-registration-44819465227 Please note: currently the Eventbrite description says 2018, but it is wrong - use the "Register" button to see the correct dates.

  • IT in healthcare - getting your product to market [Regulatory Compliance & IP]

    IT in healthcare applications, devices and systems has seen rapid growth and expansion in recent times. The activities in this sector will only expand over time and companies (SMEs) and researchers should be aware, knowledgeable and prepared for these changes. Join this free workshop to hear from three experts in the field from an operational, intellectual property and regulatory perspective to assist you in getting your product to market. Expert Panel Lusia Guthrie With over 35 years in the pharmaceutical and bioscience industries, Lusia Guthri is an experienced CEO and medtech entrepreneur. She has a passion and proven track record in bringing innovative products to global markets, embracing the entire process from company formation, capital raising and concept development to product launch. She has particular experience and ongoing interest in the development and commercialisation of new healthcare products that embrace automation, robotics, machine learning and artificial intelligence. Rob McInnes Rob McInnes is a lawyer with a technical background in the life sciences, who has practices for more than 25 years in the commercialisation of IP and technology. He is ranked in the top tier of Australian IP commercialisation lawyers, and holds the US-based Certified Licensing Professional accreditation. Rob assists research organisations, start-ups, established businesses and investors with the capture, protection, management and licensing of IP rights. Terry Walsh Terry Walsh has over 15 years' experience with the regulated space spanning biotech, pharma, blood products and mecial devices. Walsh has started, run and led three businesses over the last decade in Australia to support the regulated industry in aspects of engineering, IT, quality and regulatory compliance. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/it-in-healthcare-getting-your-product-to-market-registration-45366992897 - be sure to select the Brisbane Event.

  • IT in healthcare - getting your product to market [Regulatory Compliance & IP]

    IT in healthcare applications, devices and systems has seen rapid growth and expansion in recent times. The activities in this sector will only expand over time and companies (SMEs) and researchers should be aware, knowledgeable and prepared for these changes. Join this free workshop to hear from three experts in the field from an operational, intellectual property and regulatory perspective to assist you in getting your product to market. Expert Panel Lusia Guthrie With over 35 years in the pharmaceutical and bioscience industries, Lusia Guthri is an experienced CEO and medtech entrepreneur. She has a passion and proven track record in bringing innovative products to global markets, embracing the entire process from company formation, capital raising and concept development to product launch. She has particular experience and ongoing interest in the development and commercialisation of new healthcare products that embrace automation, robotics, machine learning and artificial intelligence. Rob McInnes Rob McInnes is a lawyer with a technical background in the life sciences, who has practices for more than 25 years in the commercialisation of IP and technology. He is ranked in the top tier of Australian IP commercialisation lawyers, and holds the US-based Certified Licensing Professional accreditation. Rob assists research organisations, start-ups, established businesses and investors with the capture, protection, management and licensing of IP rights. Terry Walsh Terry Walsh has over 15 years' experience with the regulated space spanning biotech, pharma, blood products and mecial devices. Walsh has started, run and led three businesses over the last decade in Australia to support the regulated industry in aspects of engineering, IT, quality and regulatory compliance. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/it-in-healthcare-getting-your-product-to-market-registration-45366992897 - be sure to select the Adelaide Event.

  • IT in healthcare - getting your product to market [Regulatory Compliance & IP]

    IT in healthcare applications, devices and systems has seen rapid growth and expansion in recent times. The activities in this sector will only expand over time and companies (SMEs) and researchers should be aware, knowledgeable and prepared for these changes. Join this free workshop to hear from three experts in the field from an operational, intellectual property and regulatory perspective to assist you in getting your product to market. Expert Panel Lusia Guthrie With over 35 years in the pharmaceutical and bioscience industries, Lusia Guthri is an experienced CEO and medtech entrepreneur. She has a passion and proven track record in bringing innovative products to global markets, embracing the entire process from company formation, capital raising and concept development to product launch. She has particular experience and ongoing interest in the development and commercialisation of new healthcare products that embrace automation, robotics, machine learning and artificial intelligence. Rob McInnes Rob McInnes is a lawyer with a technical background in the life sciences, who has practices for more than 25 years in the commercialisation of IP and technology. He is ranked in the top tier of Australian IP commercialisation lawyers, and holds the US-based Certified Licensing Professional accreditation. Rob assists research organisations, start-ups, established businesses and investors with the capture, protection, management and licensing of IP rights. Terry Walsh Terry Walsh has over 15 years' experience with the regulated space spanning biotech, pharma, blood products and mecial devices. Walsh has started, run and led three businesses over the last decade in Australia to support the regulated industry in aspects of engineering, IT, quality and regulatory compliance. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/it-in-healthcare-getting-your-product-to-market-registration-45366992897

  • Understanding 510K for [Medical] Devices [Adelaide]

    Deloitte Adelaide

    External Entrepreneurs' Programme Adelaide Event: brings together two experts in the field that will be able to assist SMEs to understand from a regulatory and operational perspective what is required to ensure FDA - 510(K) compliance. This workshop will be valuable to both companies that have this accreditation but also those making the transition and aspire to operate in the medical devices sector. Please register via the link: https://www.eventbrite.com.au/e/understanding-510k-for-devices-registration-44819465227 For more information on this workshop, please contact Julie-Anne White on[masked]. Presenters Andrew Batty - Lincoln Consulting Group Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has experience managing regulatory teams and external consultants to facilitate local and international device distribution. Arthur Brandwood - Brandwood Biomedical Brandwood Biomedical is an international medical device and IVD regulatory consultancy, with deep knowledge and experience of US FDA processes including successful traditional and de novo 510(k) submissions and preconsultation interactions with FDA – both remote and face to face. Founder and Principal Consultant Arthur Brandwood has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments in both start up companies and university applied research, has held senior roles including Director of Device Registrations at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific.

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  • Med Tech/Pharma Stories - Join the Conversation!

    Deloitte Perth

    External Entrepreneurs' Program Perth Event: Med Tech/Pharma Stories - Join the Conversation! The Department of Industry, Innovation and Science's Entrepreneurs' Programme is please to announce a Panel Seminar and Q&A session with key experts in the Biotech/Medtech/Pharma Sector. This event is open for any Biotech/Medtech/Pharma SME to attend, so don't miss out on this valuable opportunity to hear from subject matter experts and engage in a conversation about the rewards and challenges of developing a successful business in the sector! Please register via the link: https://www.eventbrite.com.au/e/med-techpharma-stories-join-the-conversation-registration-43733381722 Key Experts Andrew Batty, Lincoln Consulting Andrew is an internationally experienced and commercially driven professional with over 20 years' experience in the healthcare sector and was previously the CEO of Anatomics for 11 years. Lusia Guthrie Lusia is co-founder and former CEO of LBT Innovations Ltd. a company that has developed breakthrough technology, managed relationships with global diagnostics companies and continues to innovate and branch into new areas. In addition to capital raising and ASX listing, Lusia oversaw the development and commercialisation of LBT's two robotic and digital platforms for the automation of clinical microbiology testing. Professor Mark Kendall, Australian National University Professor Kendall is the inventor of the Nanopatch, a needle-free vaccine delivery device which is under rapid research and development to produce through spin-out company, Vaxxas. Dr Michael Thurn, Mimetica CEO of Mimetica, a VC-funded dematology company developing innovative solutions for the treatment of acne. Michael is also the COO of Botanix and has previously been the CEO of Spinifex and COO of Cytopia.

  • Understanding 510K for [Medical] Devices [Melbourne]

    Deloitte Melbourne

    External Entrepreneurs' Programme Melbourne Event: brings together two experts in the field that will be able to assist SMEs to understand from a regulatory and operational perspective what is required to ensure FDA - 510(K) compliance. This workshop will be valuable to both companies that have this accreditation but also those making the transition and aspire to operate in the medical devices sector. Please register via the link: https://www.eventbrite.com.au/e/understanding-510k-for-devices-registration-44819465227 For more information on this workshop, please contact Greg Ward on[masked] Presenters Andrew Batty - Lincoln Consulting Group Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has experience managing regulatory teams and external consultants to facilitate local and international device distribution. Arthur Brandwood - Brandwood Biomedical Brandwood Biomedical is an international medical device and IVD regulatory consultancy, with deep knowledge and experience of US FDA processes including successful traditional and de novo 510(k) submissions and preconsultation interactions with FDA – both remote and face to face. Founder and Principal Consultant Arthur Brandwood has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments in both start up companies and university applied research, has held senior roles including Director of Device Registrations at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific.

  • Med Tech/Pharma Stories - Join the Conversation!

    Deloitte Adelaide

    External Entrepreneurs' Program Adelaide Event: Med Tech/Pharma Stories - Join the Conversation! The Department of Industry, Innovation and Science's Entrepreneurs' Programme is please to announce a Panel Seminar and Q&A session with key experts in the Biotech/Medtech/Pharma Sector. This event is open for any Biotech/Medtech/Pharma SME to attend, so don't miss out on this valuable opportunity to hear from subject matter experts and engage in a conversation about the rewards and challenges of developing a successful business in the sector! Please register via the link: https://www.eventbrite.com.au/e/med-techpharma-stories-join-the-conversation-registration-38827325576 Key Experts Andrew Batty, Lincoln Consulting Andrew is an internationally experienced and commercially driven professional with over 20 years' experience in the healthcare sector and was previously the CEO of Anatomics for 11 years. Lusia Guthrie Lusia is co-founder and former CEO of LBT Innovations Ltd. a company that has developed breakthrough technology, managed relationships with global diagnostics companies and continues to innovate and branch into new areas. In addition to capital raising and ASX listing, Lusia oversaw the development and commercialisation of LBT's two robotic and digital platforms for the automation of clinical microbiology testing. Associate Professor Bernie Flynn A/Professor Bernie Flynn is a medicinal chemist and entrepreneur based at the Monash Institute of Pharmaceutical Science, Melboune. He has been Founder and CEO of two VC-backed start-up companies, Iliad Chemicals and Cincera Therapeutics and involved in a third, the Takeda/Monash spin-out, Endocomal Therapeutics. Dr Michael Thurn, Mimetica CEO of Mimetica, a VC-funded dematology company developing innovative solutions for the treatment of acne. Michael is also the COO of Botanix and has previously been the CEO of Spinifex and COO of Cytopia.