[WEBINAR] Substance-based Devices: Borderline Cases

April 5, 2023
|In Market Access
|By Marieke Moliner

SUBSTANCE-BASED DEVICES: BORDERLINE CASES

 

The qualification of a substance-based product as a medicinal product or a medical device can be challenging, with several products often being “borderline”. Providing an adequate scientifically-sound justification for qualifying substance-based products is of prime importance because it may dramatically impact the regulatory pathway (and burden) for market access.

 

In this recorded webinar, our experts Dr. Cornelia List and Dr. Adrien Marchand tell you all about:

  • Hands-on qualification and risk classification of substance-based products through examples
  • Illustration of the types of information required for justifying the presence or absence of active substances
  • Use of databases to find literature to demonstrate the absorption/absence of absorption of the constituting substances

 

WATCH THE WEBINAR

Please submit the form to watch: