Beat U. Steffen, RAC, FRAPS

Co-author; Combination Products

ISBN: 978-1-947493-86-5

Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, is the reference pharma and biologics professionals searching for. Consolidating the knowledge of more than 50 subject matter experts across 32 chapters, this book places all the laws, regulations, and guidances needed at your fingertips

Co-author; Combination Products (Chapter 30)

ISBN: 978-1-947493-63-6

Fundamentals of International Regulatory Affairs, Fifth Edition contains both new and updated information as international harmonization efforts continue. The book offers new chapters on regulatory reliance, pricing and reimbursement, and health technology assessment, as well as updated chapters on cosmetic products and veterinary medical products. Updated through May 2021, this new edition discusses the many… Mehr anzeigen

Co-author; Combination Products (Chapter 30)

ISBN: 978-1-947493-63-6

Fundamentals of International Regulatory Affairs, Fifth Edition contains both new and updated information as international harmonization efforts continue. The book offers new chapters on regulatory reliance, pricing and reimbursement, and health technology assessment, as well as updated chapters on cosmetic products and veterinary medical products. Updated through May 2021, this new edition discusses the many changes that have occurred globally and technologically over the last three years, including some due to the COVID-19 pandemic. The medical device chapters examine the global regulations for devices and in vitro diagnostic devices, from premarket through postmarket and represent the state of the art in regulatory sciences. The drug chapters review the entire lifecycle for medicinal products from clinical trial application to dossier preparation and on through postmarketing activities and requirements. They also cover products derived from biotechnology including biosimilars and vaccines. This latest edition also features a comprehensive matrix of applicable laws and regulations, a glossary of terms, abbreviations, and acronyms, and an extensive index to compliment the chapters. application. Weniger anzeigen

Reviewer; Author of Foreword

ISBN: 978-1-947493-59-9

International Combination Products provides practical guidance on navigating this exciting area of converging technologies. Combination products raise a variety of developmental, testing and regulatory challenges due to their unique melding of regulatory identities. The complexities grow even more so when innovative technologies, such as wearable products or artificial intelligence, are combined with drugs or… Mehr anzeigen

Reviewer; Author of Foreword

ISBN: 978-1-947493-59-9

International Combination Products provides practical guidance on navigating this exciting area of converging technologies. Combination products raise a variety of developmental, testing and regulatory challenges due to their unique melding of regulatory identities. The complexities grow even more so when innovative technologies, such as wearable products or artificial intelligence, are combined with drugs or biologics.

This book includes background information and practical guidelines regarding regulatory questions of these novel technologies. It takes a readily applicable approach to addressing the relevant challenges associated with merging technologies. This book explores the process from start to finish, establishing a workable regulatory strategy to bring the products to the market in a compliant and timely manner.

International Combination Products emphasizes the importance of ensuring the best possible products are delivered as swiftly as possible, but never forgetting the scientific rigor and regulatory oversight that ultimately determine failure or success. Weniger anzeigen

Author of chapter "The EU regulatory framework in the medtech business"

ISBN 978-3-7272-1694-7

Co-Author or Chapter "Importance of Design Control and Risk Management Processes in Combination Product Development"

ISBN 978-3-030-31414-9