07019nam a22005777i 4500 on1376455148 EBZ 20251029164107.0 m d cr cnu---unuuu 230419s2023 flua o 000 0 eng d EBZ eng EBZ 9781003300298 (electronic bk.) 1003300294 (electronic bk.) 1000874567 (electronic bk. : PDF) 9781000874587 (electronic bk. : EPUB) 1000874583 (electronic bk. : EPUB) 9781000874563 (electronic bk.) 9781032291628 1032291621 10.1201/9781003300298 doi 9781003300298 Taylor & Francis RS192 MED 009000 bisacsh MED 071000 bisacsh MED 072000 bisacsh TDCW bicssc MAIN The combination products handbook : a practical guide for combination products and other combined use systems / edited by Susan Neadle. Boca Raton : CRC Press, 2023. 1 online resource (480 pages) : illustrations (black and white, and colour). text txt rdacontent computer c rdamedia online resource cr rdacarrier textual sapdv EBSCOhost 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 combinationproduct is one composed of any combination of a drug and a device; a biological product anda device; a drug and a biological product; or a drug, device and a biological product. Examplesinclude prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-elutingstents, and kits containing drug administration devices co-packaged with drugs and/or biologicalproducts. This handbook provides the most up-to-date information on the development of combinationproducts, from the technology involved to successful delivery to market. The authors presentimportant and up-to-the-minute pre- and post-market reviews of combination product regulations,guidance, considerations and best practices. This handbook: Brings clarity of understanding for 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 withover 35 years of industry experience and has an outstanding team of contributors. Endorsed byAAMI - Association for the Advancement of Medical Instrumentation. EBSCOhost "EBSCO evaluates our products based on the Web Content Accessibility Guidelines (WCAG) and the related Section 508 and EN 301 549 regulations in the US and EU. Most EBSCO products are substantially conformant with WCAG 2.2 level AA." Source: https://connect.ebsco.com/s/article/EBSCO-VPATs?language=en_US. Last accessed April 22, 2025. 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. Print version record. Pharmaceutical technology. 64721 MEDICAL / Biotechnology bisacsh 63891 MEDICAL / Pharmacology bisacsh 64250 MEDICAL / Pharmacy bisacsh 64669 Neadle, Susan W., editor. 65004 Print version: Combination products handbook. Boca Raton : CRC Press, 2023 9781032291628 EBSCOhost https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3591390 EBSCOhost EBSC 3591390 92 N$T 56106 56106