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02 · Writing

Publications & technical articles

Articles, papers, and contributions to scientific journals and industry publications.

A selection of publications from recent years, reflecting the topics I have worked on across MedTech, combination products, and pharmaceutical packaging.

Need a contributor for an article, book, or industry publication? I am happy to discuss your topic.

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2019

English

Drug-Device Combination Products – An overview

Torsten Kneuss

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.

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2010

German

RFID-Unterstützung für pharmazeutische Produkte. Ökonomische Analyse und Handlungsempfehlungen aus Anwender- und Herstellerperspektiven

Torsten Kneuss

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.

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2004

German

Elektronische Signaturen – Technologien mit Potential

Dr. Norbert Witowski, Torsten Kneuss

Published by TimeKontor AG as part of the IT security study “Wie viel IT-Sicherheit braucht ein Unternehmen?”Abstract: The article discusses the goal of transitioning paper-based processes to electronic ones in order to achieve comparable or higher security. This includes clear identification, confirmation, and protection of data from alteration and unauthorized access. Electronic signatures are necessary for certain legal transactions and can be used to ensure the authenticity and integrity of electronically transmitted documents.The German Signatures Act of 1997 was the first national law of its kind and was updated in 2001 to comply with EU regulations. The Act distinguishes between four types of electronic signatures, with the qualified electronic signature being the most secure and having the highest evidentiary value. It requires a secure signature creation device and certification from a trusted service provider. Electronic signatures do not replace handwritten signatures but can be used for form-free contracts.

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