The following is a list of my publications from the last years.
2019: Drug-Device Combination Products – An overview
Author: Torsten Kneuss
Abstract: Nearly every second product of the 20 best-selling drugs is used in conjunction with at least one medical device. These so-called Drug-Device Combination Products are increasingly important in the pharmaceutical industry, as some drug delivery approaches like inhalation, injection, and the nasal application would not be possible without devices. However, the regulations are inconsistent between countries. The United States and Japan regulate such products as Combination Products, which means that the combination obtains marketing authorization under one ap- plication without a need for individual marketing authorizations for the components. In contrast to the US and Japan, only specific Drug-Device Combination Products are individually regulated in the EU.
This article reviews regulatory and quality aspects of Drug-Device Combination Products in relation to the US, EU, and Japan. Additional changes anticipated throughout the regulatory environment for Drug-Device Combination Products are also discussed.
2010: RFID-Unterstützung für pharmazeutische Produkte. Ökonomische Analyse und Handlungsempfehlungen aus Anwender- und Herstellerperspektiven
(only available in German)
Autor: Torsten Kneuss
Abstract: The pharmaceutical industry, as well as the entire healthcare sector, is within a comprehensive process of change. Innovations are the best instrument to meet this challenge. New approaches have to be implemented to increase productivity further. Additionally, continuous improvement in the safety of pharmaceutical products is necessary. Radio Frequency Identification (RFID) is a comparatively new Auto-ID technology for the automatic identification of objects using electromagnetic waves. RFID transponders can be used to communicate via a reader. Besides being used for identification, the storage of data on the transponder also is possible. For example, transponders can be used in the form of a label for pharmaceutical packaging. This thesis analyzes existing and potential applications of RFID for the healthcare sector with focus on pharmaceutical products. Besides the possible applications, this study investigates how pharmaceutical companies can develop and evaluate projects with regards to RFID.
2004: Elektronische Signaturen – Technologien mit Potential
(only available in German)
Autor: Dr. Norbert Witowski, Torsten Kneuss
Published by TimeKontor AG as part of the IT security study “Wie viel IT-Sicherheit braucht ein Unternehmen?”