Benefits and Challenges from Pharmaceutical Industry Perspective

09:35 - 10:10

The presentation will provide an overview about Software (e.g., Apps) which is regulated as a medical device or as device-constituent part of a combination product and is either being used in conjunction with drug-delivery devices or as a support tool for patients, HCPs or other users in the course of the use of drug products. Main topics will be an overview of the applicable regulations and practical experience gained from an existing medical software solution.

Torsten Kneuss, QA Manager Combination Products, Bayer