Introduction to Drug-Device Combination Products Regulation

Introduction to Drug-Device Combination Products Regulation
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Institut:
Autor: Salma Michor, PhD, MSc, MBA
ISBN: 9783903024953
Seitenanzahl: 96
Herausgeber: TU Verlag
Erscheinungsort: Wien

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Introduction to Drug-Device Combination Products Regulation

Drug-device combination products present novel product developments and allow for safer and more effective treatments and individualized therapy. This book looks at the regulatory approval challenges and guidance’s available to help people working in the combination product regulatory environment, address all relevant regulatory requirements while avoiding redundancies.
Topics covered include definitions is different regions including the US, the EU, Australia and Japan, the number and type of applications and the choice of the lead center for evaluation (drug or device), the type of documentation required and development considerations. The quality requirements for different types of combination products is analyzed including single entity products, combination products which are co-packaged and combination products sold separately or cross referenced. Other topics covered include post-market issues related to both cross labeled products sold separately and single entity and co-packaged products and Life-Cycle-Management issues.

Salma Michor, PhD, MSc, MBA

Salma Michor, PhD, MSc, MBA,
The author has worked for many years in the pharmaceutical and medical device industries with a main focus on combination products. She is the academic advisor and project manager of the Master’s course EU Regulatory Affairs, University of Krems, Austria and teaches regulatory affairs and clinical strategies. She and is an independent expert to the European Commission since 2004. Michor is a board member of the Regulatory Affairs Professionals Society (RAPS) European office and is acting treasurer of the US based RAPS. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU and global scope).

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