Beat U. Steffen, RAC, FRAPS
Düdingen, Freiburg, Schweiz
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confinis is a consultancy specializing in providing advice and services to the medical…
Artikel von Beat U. Steffen, RAC, FRAPS
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MDR Article 117 – a look into the Crystal Ball (Part 6)
MDR Article 117 – a look into the Crystal Ball (Part 6)
Von Beat U. Steffen, RAC, FRAPS
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MDR Article 117 – a look into the Crystal Ball (Part 5)
MDR Article 117 – a look into the Crystal Ball (Part 5)
Von Beat U. Steffen, RAC, FRAPS
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MDR Article 117 – a look into the Crystal Ball (Part 4)
MDR Article 117 – a look into the Crystal Ball (Part 4)
Von Beat U. Steffen, RAC, FRAPS
Aktivitäten
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Less than 10 years ago, the first biosimilar was approved by the FDA. Now, there are over 50 approved therapies with dozens more in development…
Less than 10 years ago, the first biosimilar was approved by the FDA. Now, there are over 50 approved therapies with dozens more in development…
Beliebt bei Beat U. Steffen, RAC, FRAPS
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📣 FREE Presentation in London🇬🇧🎡🏰: IEC 60601-1, 4th Edition, & more — With Leo Eisner & Ian Sealey What’s on the menu🍰? • Where are we…
📣 FREE Presentation in London🇬🇧🎡🏰: IEC 60601-1, 4th Edition, & more — With Leo Eisner & Ian Sealey What’s on the menu🍰? • Where are we…
Beliebt bei Beat U. Steffen, RAC, FRAPS
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Veröffentlichungen
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RAPS Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
RAPS
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 -
Fundamentals of International Regulatory Affairs, 5th Edition
RAPS
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…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. -
International Combination Product
RAPS
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…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. -
Bio- and Medtech Entrepreneurship – from start-up to exit, 2nd Edition
Università della Svizzera Italiana
Author of chapter "The EU regulatory framework in the medtech business"
ISBN 978-3-7272-1694-7 -
Development of Biopharmaceutical Drug-Device Products
AAPS – Advances in the Pharmaceutical Sciences Series
Co-Author or Chapter "Importance of Design Control and Risk Management Processes in Combination Product Development"
ISBN 978-3-030-31414-9
Auszeichnungen/Preise
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FRAPS (RAPS Fellow)
RAPS
The RAPS Fellows program recognizes senior regulatory professionals for their significant contributions and leadership in advancing the regulatory profession and the Regulatory Affairs Professionals Society (RAPS). In addition, RAPS Fellows are an important resource for helping the organization by supporting mentoring efforts, developing strategic directions, implementing special initiatives and advancing RAPS’ international development efforts.
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German
Muttersprache oder zweisprachig
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English
Fließend
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French
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Italian
Fließend
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Jetzt anmelden und ansehenWeitere Aktivitäten von Beat U. Steffen, RAC, FRAPS
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Ampersand Capital Partners is proud to be named a GrowthCap Top Private Equity Firm of 2024! We are grateful to our partners who helped make this…
Ampersand Capital Partners is proud to be named a GrowthCap Top Private Equity Firm of 2024! We are grateful to our partners who helped make this…
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🌟 Proud to Support the Future of Health Grant! 🌟 Today, #confinis attended the annual Future of Health Grant (FoHG) conference, focused on…
🌟 Proud to Support the Future of Health Grant! 🌟 Today, #confinis attended the annual Future of Health Grant (FoHG) conference, focused on…
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𝗪𝗶𝗹𝗹 𝘆𝗼𝘂 𝗷𝗼𝗶𝗻 𝘂𝘀 𝗮𝘁 #𝗥𝗔𝗣𝗦𝗖𝗼𝗻𝘃𝗲𝗿𝗴𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰 𝗶𝗻 𝗟𝗼𝗻𝗴 𝗕𝗲𝗮𝗰𝗵? Successful and meaningful interactions with…
𝗪𝗶𝗹𝗹 𝘆𝗼𝘂 𝗷𝗼𝗶𝗻 𝘂𝘀 𝗮𝘁 #𝗥𝗔𝗣𝗦𝗖𝗼𝗻𝘃𝗲𝗿𝗴𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰 𝗶𝗻 𝗟𝗼𝗻𝗴 𝗕𝗲𝗮𝗰𝗵? Successful and meaningful interactions with…
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🎉 Celebrating 1 Year of breathe medical AG! 🎉 One year ago, we started this incredible journey with our signatures on a pile of documents…
🎉 Celebrating 1 Year of breathe medical AG! 🎉 One year ago, we started this incredible journey with our signatures on a pile of documents…
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At THYSOL Group, we make a significant impact in several key areas: 1. Enhancing Health and Recovery We provide high-quality medical products, such…
At THYSOL Group, we make a significant impact in several key areas: 1. Enhancing Health and Recovery We provide high-quality medical products, such…
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Did you know that the Bonebridge 3.5mm Proximal Tibia System was named after the extraordinary Poya Bridge in Fribourg, Switzerland? At 196 meters…
Did you know that the Bonebridge 3.5mm Proximal Tibia System was named after the extraordinary Poya Bridge in Fribourg, Switzerland? At 196 meters…
Beliebt bei Beat U. Steffen, RAC, FRAPS
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More pictures from the RAPS San Francisco Chapter In-person event yesterday. Gail Rodriguez from the FDA visited Regulatory Affairs Professionals…
More pictures from the RAPS San Francisco Chapter In-person event yesterday. Gail Rodriguez from the FDA visited Regulatory Affairs Professionals…
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#ExpandingSelfcare 💙 Ypsomed has been supplying products like the reusable ServoPen to China for over 15 years 👍. As demand shifts toward…
#ExpandingSelfcare 💙 Ypsomed has been supplying products like the reusable ServoPen to China for over 15 years 👍. As demand shifts toward…
Beliebt bei Beat U. Steffen, RAC, FRAPS
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Distalmotion will be showcasing the Dexter® Robotic System at AMERICAN HERNIA SOCIETY 2024! Please register for a clinical demonstration to…
Distalmotion will be showcasing the Dexter® Robotic System at AMERICAN HERNIA SOCIETY 2024! Please register for a clinical demonstration to…
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Ist dieses schöngefärbte Fazit angesichts der harten Fakten (Bürokratieflut, Fachkräftemangel und nicht erhältliche Medikamente und Medtechprodukte)…
Ist dieses schöngefärbte Fazit angesichts der harten Fakten (Bürokratieflut, Fachkräftemangel und nicht erhältliche Medikamente und Medtechprodukte)…
Beliebt bei Beat U. Steffen, RAC, FRAPS
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Today is our last day in fabulous South Africa!! I have enjoyed my time with Healthcare Professionals studying the healthcare system here in South…
Today is our last day in fabulous South Africa!! I have enjoyed my time with Healthcare Professionals studying the healthcare system here in South…
Beliebt bei Beat U. Steffen, RAC, FRAPS