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Masterclass: How does the Regulatory Strategy in Digital Health evolve with the Product?

6th June 2023 @ 10:45AM EDT

The regulatory landscape for any medical device can be difficult to navigate. For digital technologies, the complexity only grows. To ensure your regulatory strategy evolves effectively throughout the product development lifecycle, it is essential to stay up-to-date with the latest policies and best practices. How can you approach this? Join this masterclass to find out! 


During this interactive session, Nikki Batista (Vice President, Digital Health Regulatory Affairs, MCRA) will walk us through the best steps and policies to be aware of when approaching regulation of a digital health solution within the U.S. Specifically we will cover: 


  1. Where we were: Navigating the redefined “medical device” according to the 21st Century Cures Act.
  2. Where we are: Leveraging the Clinical Decision Support Software Policy within your product development lifecycle.
  3. Where we are going: Understand what the Predetermined Change Control Plan Policy is and how to incorporate it into your product development lifecycle.

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: How does the Regulatory Strategy in Digital Health evolve with the Product?

Nikki Batista
Vice President, Digital Health Regulatory Affairs, MCRA
Ashutosh Malhotra
Digital Business Development & Innovation Scouting Manager Europe at Daiichi Sankyo Europe GmbH
Apply to Attend

Masterclass: How does the Regulatory Strategy in Digital Health evolve with the Product?

Nikki Batista
Vice President, Digital Health Regulatory Affairs, MCRA

Join this HealthXL Event today:

Participate in this Digital Health Sprint in order to:
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6th June 2023 @ 10:45AM EDT

The regulatory landscape for any medical device can be difficult to navigate. For digital technologies, the complexity only grows. To ensure your regulatory strategy evolves effectively throughout the product development lifecycle, it is essential to stay up-to-date with the latest policies and best practices. How can you approach this? Join this masterclass to find out! 


During this interactive session, Nikki Batista (Vice President, Digital Health Regulatory Affairs, MCRA) will walk us through the best steps and policies to be aware of when approaching regulation of a digital health solution within the U.S. Specifically we will cover: 


  1. Where we were: Navigating the redefined “medical device” according to the 21st Century Cures Act.
  2. Where we are: Leveraging the Clinical Decision Support Software Policy within your product development lifecycle.
  3. Where we are going: Understand what the Predetermined Change Control Plan Policy is and how to incorporate it into your product development lifecycle.

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.

Apply to AttendRegister to AttendApply to Attend

Participants

Participants

Nikki Batista

Vice President, Digital Health Regulatory Affairs, MCRA

Ashutosh Malhotra

Digital Business Development & Innovation Scouting Manager Europe at Daiichi Sankyo Europe GmbH

Paula Salme Sandrak

Digital Health Product Strategist, Bayer

Acacia Parks

Lead Consultant and Founder, Liquid Amber Consulting

Weronika Michaluk

Principal , HTD Health

Gazal Vakili

Director, Digital Health Innovation, Sumitomo Pharma America Holdings, Inc.

Corne de Jong

CFO, Healios

Benoit Tyl

IEG medical advisor for Integrated care Cardiology, Bayer

Mansa Shroff

Head of Partnerships at WKD.SMRT

Simon Bock

Market Access Manager, Tiefenbacher Group

Wee Wen Leow

Regulatory Affairs Manager, BIOTRONIK

Marc Blanchard

Chief Development Officer - CDO at ATREON SA

Ken Skodacek

Center for Devices and Radiological Health, FDA

Fredrik Mannerstråle

Senior Regulatory Manager, OnDosis

Number of Participants


Up to 12
Date  
June 6, 2023
Community

Masterclass: How does the Regulatory Strategy in Digital Health evolve with the Product?

The regulatory landscape for any medical device can be difficult to navigate. For digital technologies, the complexity only grows. To ensure your regulatory strategy evolves effectively throughout the product development lifecycle, it is essential to stay up-to-date with the latest policies and best practices. How can you approach this? Join this masterclass to find out! 


During this interactive session, Nikki Batista (Vice President, Digital Health Regulatory Affairs, MCRA) will walk us through the best steps and policies to be aware of when approaching regulation of a digital health solution within the U.S. Specifically we will cover: 


  1. Where we were: Navigating the redefined “medical device” according to the 21st Century Cures Act.
  2. Where we are: Leveraging the Clinical Decision Support Software Policy within your product development lifecycle.
  3. Where we are going: Understand what the Predetermined Change Control Plan Policy is and how to incorporate it into your product development lifecycle.

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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  • Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
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September 22, 2023
September 2023 Global Gathering Event Recap Tech in Clinical Trials: It will work!
September 2023 Global Gathering Event Recap Tech in Clinical Trials: It will work!
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August 31, 2023
Tess’ Top Takes from this Month’s Meetings in Digital Health: August 2023
Tess’ Top Takes from this Month’s Meetings in Digital Health: August 2023
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August 25, 2023
This September, our spotlight series is all about medical affairs’ role in digital health!
This September, our spotlight series is all about medical affairs’ role in digital health!
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Masterclass: How does the Regulatory Strategy in Digital Health evolve with the Product?

6th June 2023 @ 10:45AM EDT
Digital Therapeutics (DTx)

Masterclass: How does the Regulatory Strategy in Digital Health evolve with the Product?

6th June 2023 @ 10:45AM EDT
Digital Therapeutics (DTx)
Nikki Batista
Vice President, Digital Health Regulatory Affairs, MCRA
LinkedIn Profile
Ashutosh Malhotra
Digital Business Development & Innovation Scouting Manager Europe at Daiichi Sankyo Europe GmbH
LinkedIn Profile
Paula Salme Sandrak
Digital Health Product Strategist, Bayer
LinkedIn Profile
Acacia Parks
Lead Consultant and Founder, Liquid Amber Consulting
LinkedIn Profile
Weronika Michaluk
Principal , HTD Health
LinkedIn Profile
Gazal Vakili
Director, Digital Health Innovation, Sumitomo Pharma America Holdings, Inc.
LinkedIn Profile
Corne de Jong
CFO, Healios
LinkedIn Profile
Benoit Tyl
IEG medical advisor for Integrated care Cardiology, Bayer
LinkedIn Profile
Mansa Shroff
Head of Partnerships at WKD.SMRT
LinkedIn Profile
Simon Bock
Market Access Manager, Tiefenbacher Group
LinkedIn Profile
Wee Wen Leow
Regulatory Affairs Manager, BIOTRONIK
LinkedIn Profile
Marc Blanchard
Chief Development Officer - CDO at ATREON SA
LinkedIn Profile
Ken Skodacek
Center for Devices and Radiological Health, FDA
LinkedIn Profile
Fredrik Mannerstråle
Senior Regulatory Manager, OnDosis
LinkedIn Profile

Masterclass: How does the Regulatory Strategy in Digital Health evolve with the Product?

The regulatory landscape for any medical device can be difficult to navigate. For digital technologies, the complexity only grows. To ensure your regulatory strategy evolves effectively throughout the product development lifecycle, it is essential to stay up-to-date with the latest policies and best practices. How can you approach this? Join this masterclass to find out! 


During this interactive session, Nikki Batista (Vice President, Digital Health Regulatory Affairs, MCRA) will walk us through the best steps and policies to be aware of when approaching regulation of a digital health solution within the U.S. Specifically we will cover: 


  1. Where we were: Navigating the redefined “medical device” according to the 21st Century Cures Act.
  2. Where we are: Leveraging the Clinical Decision Support Software Policy within your product development lifecycle.
  3. Where we are going: Understand what the Predetermined Change Control Plan Policy is and how to incorporate it into your product development lifecycle.

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.

When:
6th June 2023 @ 10:45AM EDT
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