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06 Jun 2023 | 02:45 PM GMT

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

Anchored by:

Nikki Batista
VP, Digital Health
WHOOP

Participants:

Nikki Batista VP, Digital HealthWHOOP
Nikki Batista
VP, Digital HealthWHOOP
Julie Carty Head of GrowthHLTH Community
Julie Carty
Head of GrowthHLTH Community
Acacia Parks VP Regulatory Compliance and EngineeringAvania
Acacia Parks
VP Regulatory Compliance and EngineeringAvania
Ashutosh Malhotra Director Digital Health Strategy & PartnersDaiichi Sankyo
Ashutosh Malhotra
Director Digital Health Strategy & PartnersDaiichi Sankyo
Benoit Tyl Medical Advisor, Integrated Care CardiologyBayer AG
Benoit Tyl
Medical Advisor, Integrated Care CardiologyBayer AG
Fredrik Mannerstråle Senior Regulatory ManagerOnDosis
Fredrik Mannerstråle
Senior Regulatory ManagerOnDosis
Marc Blanchard Founder & CEOATREON
Marc Blanchard
Founder & CEOATREON
Paula Salme Sandrak Digital Health Product StrategistBayer AG
Paula Salme Sandrak
Digital Health Product StrategistBayer AG
Simon Bock Market Access ManagerTiefenbacher Pharmaceuticals
Simon Bock
Market Access ManagerTiefenbacher Pharmaceuticals
Wee Wen Leow Regulatory Affair ManagerBiotronik NRO
Wee Wen Leow
Regulatory Affair ManagerBiotronik NRO
Weronika Michaluk MedTech Practice LeadHTD Health
Weronika Michaluk
MedTech Practice LeadHTD Health

About this Meeting

Each Masterclass is led by an expert anchor in their field as they dive into their specialty topic in front of a small intimate audience of 8-12 participants. Masterclasses also have an interactive element, allowing you a safe space to share your thoughts and experiences as well as pose questions to the expert anchors.

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.