防詐3要訣：不聽信、不操作、掛斷電話 
The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems
COMBINATION PRODUCTS HANDBK
內容簡介
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), "a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product." Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices.
This handbook:
- Brings clarity of understanding for global combination products guidance and regulations
- Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market
- Reviews medical product classification and assignment issues faced by global regulatory authorities and industry
The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI - Association for the Advancement of Medical Instrumentation.
作者介紹
Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others. Susan's leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA's 2021 Awards for Regulatory Affairs Excellence. She serves as Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership, technical skills, and complex program management experience to provide international quality & compliance, regulatory, design excellence and executive advisory consulting services to the pharmaceutical, biotech and medical device industries. Among her significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, lead author on the AAMI Combination Products Steering Committee, active member in Combination Products Coalition, and serves as faculty at AAMI and at University of Maryland Baltimore County Campus College of Natural and Mathematical Sciences for Combination Products Curricula.
Susan retired from Johnson & Johnson, where her distinguished 26+ year-career included integral leadership roles in R&D, Quality Engineering, Design-to-Value, and Quality Systems Management, spanning pharmaceuticals/biotech, medical devices, and consumer health sectors, as well as strategic leadership at J&J corporate level. She served as Chair of J&J's Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J's cross-sector Combination Products Community of Practice. Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet Combination Products health authority regulations for Janssen, J&J's Pharmaceutical sector, and was awarded the Johnson Medal for excellence in Research and Development.
Susan also served as Executive Director and Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She was as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction.
規格
退貨說明
退貨須知：
- 依照消費者保護法的規定，您享有商品貨到次日起七天猶豫期(含例假日)的權益(請注意！猶豫期非試用期)，辦理退貨之商品必須是全新狀態(不得有刮傷、破損、受潮)且需完整(包含全部商品、配件、原廠內外包裝、贈品及所有附隨文件或資料的完整性等)。
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依「通訊交易解除權合理例外情事適用準則」，下列商品不適用七日猶豫期，除產品本身有瑕疵外，不接受退貨：
- 易於腐敗、保存期限較短或解約時即將逾期。(如:生鮮蔬果、乳製品、冷凍冷藏食材、蛋糕)
- 依消費者要求所為之客製化給付。(如:客製印章、鋼筆刻字)
- 報紙、期刊或雜誌。
- 經消費者拆封之影音商品或電腦軟體。
- 非以有形媒介提供之數位內容或一經提供即為完成之線上服務，經消費者事先同意始提供。(如:電子書)
- 已拆封之個人衛生用品。(如:內衣褲、襪類、褲襪、刮鬍刀、除毛刀等貼身用品)
- 國際航空客運服務。
若您退貨時有下列情形，可能被認定已逾越檢查商品之必要程度而須負擔為回復原狀必要費用(整新費)，或影響您的退貨權利，請您在拆封前決定是否要退貨：
- 以數位或電磁紀錄形式儲存或著作權相關之商品(包含但不限於CD、VCD、DVD、電腦軟體等) 包裝已拆封者(除運送用之包裝以外)。
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- 衣飾鞋類/寢具/織品(包含但不限於衣褲、鞋子、襪子、泳裝、床單、被套、填充玩具)或之商品缺件(含購買商品、附件、內外包裝、贈品等)或經剪標或下水或商品有不可回復之髒污或磨損痕跡。
- 食品、美容/保養用品、內衣褲等消耗性或個人衛生用品、商品銷售頁面上特別載明之商品已拆封者(除運送用之包裝外一切包裝、包括但不限於瓶蓋、封口、封膜等接觸商品內容之包裝部分)或已非全新狀態(外觀有刮傷、破損、受潮等)與包裝不完整(缺少商品、附件、原廠外盒、保護袋、配件紙箱、保麗龍、隨貨文件、贈品等)。
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