Omnia Health Live Americas
Catch up on the content sessions from Omnia Health Live Americas, now available on demand! These sessions bring together policy drivers, thought leaders, expert clinicians and decision-makers in order to transform healthcare's most pressing challenges through collaboration and empowerment.
Simply click on the sessions that interest you, fill in your details and watch for free!
EU perspective on Medical Devices in 2021: Analysis of the NEW requirements by the MDR & BREXIT
Sponsored by Obelis Academy
2021 is expected to be a unique year by the coming into force of 2 major events within the sector of medical devices in the European Market:
January 1st 2021Â - The final departure of the UK from the European single market (BREXIT)
May 26th 2021Â - The coming into force of the NEW Medical Device Regulation (MDR). Â
The MHRA (UK Authority on medical devices) has recently published a guidance document covering the post-Brexit era, giving a new outlook of the long awaited UK regulations to be applied to medical device manufacturers wishing to place their devices on the UK market after January 1st. The MDR introduces a complete set of NEW requirements which require on average 18 months of preparatory work to achieve compliance – with only 6 months to the Date of Application (DoA), manufacturers must ensure they have taken all necessary actions.
Speaker:
- Doram Elkayam, COO, Obelis Group
Moderator:
- Bianca Sofian, Consultant Regulatory Affairs Department, Obelis Group
The use of non-invasive ventilator and high flow oxygen therapy in the COVID-19
Sponsored by Yuwell
The world stopped working suddenly due to the COVID-19 outbreak. As a professional medical equipment manufacturer, Yuwell spares no effort to battle with the epidemic. Especially Yuwell's non-invasive ventilators, have been actively participating in the frontline of the global epidemic. Yuwell ventilators not only provide stable services for patients in China annually, but also are one of the important forces to against COVID-19 in Wuhan. ‘Half of the non-invasive ventilators supporting Wuhan are from Yuwell. Yuwell won't stop manufacturing even the supply chain is tight now. Virus has no borders, and love has no boundaries. Thank you for supporting Yuwell, still we will try our best to against COVID-19. Let professional equipment benefit every patient who is battling the epidemic.
Speaker:
- Steven Wang, Product Director, YuwellÂ
Moderator:
- Roland Chen, Product Manager, Yuwell
IoT in the health ecosystem
In association with IHA
Moderator:Â
- Scott Hondros, Senior Vice President, Infinite Leap, North Carolina, USAÂ
Panelists:Â
- Youssef Ali, Principal Mobility and Digital Health Architect, Henry Ford Health System, Minnesota, USA
- David S Grant, Director of Marketing, Honeywell Building Technologies, Toronto, Canada
- Fawzi Behmann, President, TelNet Management Consulting, Texas, USA
FDA regulation of health-related software—What is actively regulated by FDA? What is not?Â
This session will provide a general overview of what types of health-related software FDA does and does not regulate, and a summary of the regulatory requirements with which companies must comply.
Presenters:Â
- Neil O'Flaherty, Partner, Amin Talati Wasserman, Washington DC, USAÂ
- Evan Phelps, Partner, Amin Talati Wasserman, Washington DC, USA Â
- Shelly Garg, Partner, Amin Talati Wasserman, Washington DC, USAÂ
When IFU’s and the real world do not align with your sterile processing practices / policiesÂ
In association with IAHCSMMÂ
Presenters:
- Damien Berg, Regional Manager Sterile Processing, UCHealth, Colorado, USA
- Brian Reynolds, Assistant Chief of Sterile Processing Service, VA Medical, Processing Service President of IAHCSMM 2020, Florida, USA
- Arthur Henderson, Senior Clinical Education Specialist South Eastern Zone, STERIS Corporation Healthcare, Ohio, USA
- Jill E. Holdsworth, Manager, Infection Prevention Department, Emory University Hospital Midtown, Atlanta, USA
KEYNOTE: Space health as an analog for Earth
Presenter:
- Dr Aenor Sawyer, Chief Health Innovation Officer for the NASA Funded Translational Research Institute for Space HealthÂ
Healthcare in the USA: the impact of COVID-19 and the electionÂ
COVID-19 has drastically changed the healthcare system in the USA, showcasing the challenges and what needs to change in order to move forward with a stronger healthcare system.
Moderator:Â Â
- Patrick Riley, Principal Healthcare Analyst, Frost and Sullivan, Texas, USAÂ
Panelists:Â
- Trip Pilgrim, Healthcare Consultant, Texas, USA
- Greg Caressi, Global BU Leader & Senior Vice President, Transformational Health, Frost & Sullivan, California, USA
- Felipe Vazquez, CEO, Vazquez and Associates Global Medical Supply, Texas, USA
- Dr Hermann Williams, Managing Director and Chief Physician Executive, BDO, Nashville, USA
- Elliot Sloane, President, Executive Director and Founder, Foundation for Living, Wellness and Health, Florida, USA
Colombia: Opportunities and Regulatory ConsiderationsÂ
In association with SPI
Hear about the opportunities to open a business in Colombia, and get an in-depth look at the regulatory considerations to do so.
Presenters:Â
- Alvaro Rincon, General Director, SPI, Bogota, ColombiaÂ
- Isabel Sanin, Regulatory Affairs Director, SPI, Bogota, ColombiaÂ
Governmental Market System Changes for MDs Mexico
In association with MEDISI AmericaÂ
Presenter:
- MarÃa Luisa Gutiérrez, CEO, MEDISI America, Mexico City, MexicoÂ
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Adoption and penetration of high-tech equipment in Latin AmericaÂ
In association with GHIÂ
This session will cover:
- The presence of certain key modalities
- Review the Health Tech Adoption Model
- Explore where Health Tech adoption stands and what are some of the roadblocks to adoption.
Moderator:Â
- Guillaume Corpart, Founder & CEO, Global Health Intelligence, Florida, USAÂ
Panelists:Â
- Daniel Cloutier, CEO, LOK Corporation, Montreal, CanadaÂ
- Axel Lopez, Marketing and Sales Manager Director, International Business and Projects, ELMED Company, Orlando, FloridaÂ
- Pablo Pereira, Co-Founder and COO, Armor Bionics, Montevideo, UruguayÂ
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Global strategies for medical tourism in the COVID worldÂ
An interactive discussion on how strategies have changed in the Americas region on medical tourism; especially with the challenge of COVID
Moderator:Â
- Cornelius Conboy, Director, Faturhelp, Rio de Janeiro, BrazilÂ
Panelists:Â
- Dr Graccho Alvim, Director, Hospital Association of Rio de Janeiro, Rio de Janeiro, Brazil Â
- Bill Cook, Director of Business Development & Marketing, Global Healthcare Accreditation for Medical Travel Services, San Jose, Costa RicaÂ
- Karen H. Timmons, CEO, Global Healthcare Accreditation for Medical Travel Services, Chicago, USAÂ
Regulatory affairs for the Canadian marketÂ
In association with LOK North AmericaÂ
Learn more about the regulatory affairs in the Canadian market
Presenter:Â
- Louis-Paul Marin, President and Founder, LOK North America, Quebec, CanadaÂ
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Argentina Medical Devices Regulatory Framework and Key Updates // Marco Regulatorio y Actualizaciones Clave para Dispositivos Médicos en Argentina
Content driven by MMGC
Resumen de la legislación regulatoria, vÃas y tiempos de registro para dispositivos médicos en Argentina. Cambios y tendencias post Covid 19.
Regulatory legislation overview, registration pathways, timelines for medical devices in Argentina. Post Pandemic changes and trends
Presenters:Â
- MarÃa Magdalena Ferrari del Sel, Regulatory Affairs International Senior Consultant, MMGC SRL, Buenos Aires, ArgentinaÂ
- Monica Mabel Guaita, CEO and Founding Partner, MMGC SRL, Buenos Aires, ArgentinaÂ
The importance of Setting a Regulatory Strategy to access the Latin American Market- Regulatory Overview and Post Pandemic Trends // La importancia de Plantear una Estrategia Regulatoria para Acceder al Mercado de Latinoamérica- Marco Regulatorio y Tendencias Post Covid 19
Content driven by MMGC
Conocimiento de los marcos regulatorios de los diferentes paÃses de Latinoamérica, principales inconvenientes y oportunidades derivadas de un enfoque regional y planteo de un plan regulatorio estratégico. Escenarios presentes y futuros en Brasil, Mexico Colombia – Tendencias Regulatorias Regionales e impacto de la pandemia Covid 19.
Insight into main LatAm countries´ regulatory frameworks, main drawbacks and opportunities resulting from an organized regional approach and strategic regulatory plan. Present and possible future scenarios in Brazil, Mexico , Colombia - Regional Regulatory trends and impact of Covid 19 pandemic.
Presenters:Â
- Mónica Mabel Guaita, CEO and Founding Partner, MMGC SRL, Buenos Aires, ArgentinaÂ
- Vanina Montero, Senior Latam Regulatory Affairs Specialist, MMGC SRL, Buenos Aires, ArgentinaÂ
- Patricia Luchiari Verrone, Regulatory Affairs Manager, Vera Rosas Group, San Pablo, BrazilÂ
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Health Care Structure and Steps to enter the LatAm Medical Devices Market- Impact of Covid 19 pandemic - Regional Trends // Estructura del Sistema de Salud y Pasos para Ingresar en el Mercado de Dispositivos Médicos en LatAm- Impacto de la pandemia por Covid 19- Tendencias Regionales
Content driven by MMGC
Estructura del Sistema de Salud y Pasos para ingresar al Mercado Latinoamericano de Dispositivos Médicos- Impacto de la pandemia Covid 19- Tendencias Regionales
Health Care Structure and Steps to enter different LatAm markets. Post pandemic impact and trends in supply chain, availability and highlights of changes in regulations related to medical devices in the region.
Moderators:Â
- MarÃa Magdalena Ferrari del Sel, Regulatory Affairs International Senior Consultant, MMGC SRL, Buenos Aires, ArgentinaÂ
- Monica Mabel Guaita, CEO and Founding Partner, MMGC SRL, Buenos Aires, ArgentinaÂ
Speakers:Â
- Marisol Sánchez González, Executive Director ALDIMED, Latin American Medical Device Alliance, Bogota, ColombiaÂ
- Angelica Garuti Marques, Regulatory Affairs Manager, ABIMED, Brazilian High Technology HealthCare Industry Association, Sao Paulo, BrazilÂ
- Eduardo Paez, CADIEM, Medical Devices Importers and Distributors Association, Buenos Aires, ArgentinaÂ
- Martin Navia, CADIEM, Medical Devices Importers and Distributors Association, Buenos Aires, ArgentinaÂ