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Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
Obtaining SaMD approval is no easy task, as it requires rigorous evidence generation and efficacy demonstration to ensure patient safety and usability. This becomes even more challenging when the SaMD is designed to be agnostic, meaning that it can be applied to multiple conditions. In this case, the SaMD must undergo extensive clinical evaluations, provide evidence of its performance, usability, and safety in various scenarios, and demonstrate its added value for patients and providers. This is a complex and demanding process, and can lead to the development of innovative and effective solutions that can address unmet needs and improve health outcomes across different populations and settings.
How can SaMD developers and owners navigate these complexities and unlock the opportunities of agnostic SaMD? Join this masterclass to find out!
In this session, Arrash Yassaee and Mani Shanmugham (Huma) will bring us through a case study of evidence requirements for achieving multi-condition SaMD, and the implications this brings. Specifically, we will delve into:
- Implications of achieving multi-condition SaMD approval. What potential benefits and use cases can agnostic SaMD unlock?
- Evidence generation strategies. What are best practices and strategies for generating robust and reliable evidence to achieve multi condition SaMD approval?
- Geographical variations in evidence requirements. How do evidence requirements and expectations for SaMD differ between the EU and US?
We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.
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Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
Join this HealthXL Event today:
Participate in this Digital Health Sprint in order to:
- Deep dive into a topic over 2 focused sessions.
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- Grow your network with our break out sessions.
You actively participate in this discussion. Spaces are limited to 8 - 12 people, allowing you to focus on quality in-depth conversations.
Don't miss your opportunity to connect with senior leaders to shape the future of digital health. Because only if you are prepared now can you lead the future.
Obtaining SaMD approval is no easy task, as it requires rigorous evidence generation and efficacy demonstration to ensure patient safety and usability. This becomes even more challenging when the SaMD is designed to be agnostic, meaning that it can be applied to multiple conditions. In this case, the SaMD must undergo extensive clinical evaluations, provide evidence of its performance, usability, and safety in various scenarios, and demonstrate its added value for patients and providers. This is a complex and demanding process, and can lead to the development of innovative and effective solutions that can address unmet needs and improve health outcomes across different populations and settings.
How can SaMD developers and owners navigate these complexities and unlock the opportunities of agnostic SaMD? Join this masterclass to find out!
In this session, Arrash Yassaee and Mani Shanmugham (Huma) will bring us through a case study of evidence requirements for achieving multi-condition SaMD, and the implications this brings. Specifically, we will delve into:
- Implications of achieving multi-condition SaMD approval. What potential benefits and use cases can agnostic SaMD unlock?
- Evidence generation strategies. What are best practices and strategies for generating robust and reliable evidence to achieve multi condition SaMD approval?
- Geographical variations in evidence requirements. How do evidence requirements and expectations for SaMD differ between the EU and US?
We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.
Participants
Participants
Mani Shanmugham
Director QA/RA, Huma
Marcus Bates
Director - External Partners, Connected Devices/ Digital Medicine at Aptar Pharma
Gandolf Finke
Founder & MD at Mika / Fosanis
Anna-Maria Heidinger
Head of Digital Innovation Hub Europe, Daiichi Sankyo Europe GmbH
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Rafal Zasadny
Regulatory Affairs Manager at Bayer Consumer Care
Gazal Vakili
Director, Digital Health Innovation, Sumitomo Pharma America Holdings, Inc.
Weronika Michaluk
Principal , HTD Health
Ventsislav Dobrev
Global Innovation & Digital Health Solutions Manager, Ypsomed
Susanne Gruber
Strategic Advisor, Ignited Vision
Zina Manji
Sr Director of Regulatory Affairs at GSK
Arshia Gratiot
Founder and CEO, Eupnoos
David Feygin
CEO & Founder, ANAVO DX
Ralph Morales III
Director, Healthcare Innovation, Oura
Richard Bunney
Digital Health Regulation and Compliance Lead, ETHOS Ltd
Arrash Yassaee
Global Clinical Director - Evidence Generation and Information Governance, Huma
Oliver Bailey
Associate Principal, Integrated Digital Health Consulting, IQVIA
Francesca Wuttke
CEO and Founder, nen Health
Looking to connect with digital health gamechangers beyond a meeting? Join the HealthXL Digital Therapeutics Community to connect, learn and discuss:
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Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
Obtaining SaMD approval is no easy task, as it requires rigorous evidence generation and efficacy demonstration to ensure patient safety and usability. This becomes even more challenging when the SaMD is designed to be agnostic, meaning that it can be applied to multiple conditions. In this case, the SaMD must undergo extensive clinical evaluations, provide evidence of its performance, usability, and safety in various scenarios, and demonstrate its added value for patients and providers. This is a complex and demanding process, and can lead to the development of innovative and effective solutions that can address unmet needs and improve health outcomes across different populations and settings.
How can SaMD developers and owners navigate these complexities and unlock the opportunities of agnostic SaMD? Join this masterclass to find out!
In this session, Arrash Yassaee and Mani Shanmugham (Huma) will bring us through a case study of evidence requirements for achieving multi-condition SaMD, and the implications this brings. Specifically, we will delve into:
- Implications of achieving multi-condition SaMD approval. What potential benefits and use cases can agnostic SaMD unlock?
- Evidence generation strategies. What are best practices and strategies for generating robust and reliable evidence to achieve multi condition SaMD approval?
- Geographical variations in evidence requirements. How do evidence requirements and expectations for SaMD differ between the EU and US?
We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.
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Set up a free HealthXL platform account for a taste of what the community has to offer. Or talk to us about upgrading to a premium account:
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Set up a free HealthXL platform account for a taste of what the community has to offer. Or talk to us about upgrading to a premium account:
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- Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
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Our community is growing fast. Don’t miss out on your opportunity to lead the future.
The world of Digital Health in one Hub
Be ready for the future of Digital Health and join a community of passionate leaders, innovators and gamechangers.
As a HealthXL member, you get access to a wealth of information, resources and connections. From daily curated news by our in-house expert team to industry reports each retailing at €2000 - you have the world of Digital Health right at your fingertips.
Our community is growing fast. Don’t miss out on your opportunity to lead the future.
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Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications
Obtaining SaMD approval is no easy task, as it requires rigorous evidence generation and efficacy demonstration to ensure patient safety and usability. This becomes even more challenging when the SaMD is designed to be agnostic, meaning that it can be applied to multiple conditions. In this case, the SaMD must undergo extensive clinical evaluations, provide evidence of its performance, usability, and safety in various scenarios, and demonstrate its added value for patients and providers. This is a complex and demanding process, and can lead to the development of innovative and effective solutions that can address unmet needs and improve health outcomes across different populations and settings.
How can SaMD developers and owners navigate these complexities and unlock the opportunities of agnostic SaMD? Join this masterclass to find out!
In this session, Arrash Yassaee and Mani Shanmugham (Huma) will bring us through a case study of evidence requirements for achieving multi-condition SaMD, and the implications this brings. Specifically, we will delve into:
- Implications of achieving multi-condition SaMD approval. What potential benefits and use cases can agnostic SaMD unlock?
- Evidence generation strategies. What are best practices and strategies for generating robust and reliable evidence to achieve multi condition SaMD approval?
- Geographical variations in evidence requirements. How do evidence requirements and expectations for SaMD differ between the EU and US?
We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.
Join this group of peers and get a feel of what it's like to belong to a community of digital health gamechangers.
All meetings are limited to 10 people to allow for honest discussions, so apply fast or become a HealthXL member and get priority access to all meetings, latest industry reports and and much more.
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What are HealthXL Virtual Meetings?
HealthXL Virtual Meetings are private group meetings limited to 10 people across different demographic and stakeholder groups. For 75 minutes, you take a deep dive into your chosen topic and explore it from different angles. Virtual Meetings are not webinars: There is no audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And through our Community Hub, you stay up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.
How can I connect with other digital health leaders?
HealthXL brings together gamechangers of digital health to support honest discussions in small, private groups. In our Community Hub, for which you can register for free, you can follow a wide range of communities across telehealth, digital therapeutics, patient engagement and more. As a full HealthXL member, you also get access to curated news, the latest insights and an expert network to connect with. Join exclusive virtual meetings to exchange strategies, viewpoints and learnings with members from like-minded yet diverse stakeholder groups.
What are the benefits of being a HealthXL community member?
As member of HealthXL, you join a community of digital health thought leaders, innovators and game changers around the world. With your membership, you get access to hundreds of insights, reports and resources. You can browse a database with over 90k healthcare organizations and view their active strategic partnerships, commercial relationships, latest funding rounds and research. Through our in-house curated digital health newsfeed, you stay informed on the most impactful news and you can regularly meet with members to share learnings, discuss the latest developments and connect with peers of different demographical stakeholder groups. Contact us today to find out about pricing options.
Through focus groups, we bring together 6-10 thought leaders and industry stakeholders in a series of virtual meetings to collaborate around a defined topic. Each meeting gives the group the opportunity to examine, analyze and collaborate with one another around a digital health topic as well as produce a shareable result.
