Description:
Editorial Reviews
About the Author
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.
Reviews:
5.0 out of 5 stars excellent resource
great book by Susan Needle.
Books look
Book should be published in colored pages.
Visit the CRC Press Store
The Combination Products Handbook
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The Combination Products Handbook
AED41052
Quantity:
Order today to get by 7-14 business days
This item qualifies for free delivery
Imported From: United States
At BOLO, we work hard to ensure the products you receive are new, genuine, and sourced from reputable suppliers.
BOLO is not an authorized or official retailer for most brands, nor are we affiliated with manufacturers unless specifically stated on a product page. Instead, we source verified sellers, authorized distributors or directly from the manufacturer.
Each product undergoes thorough inspection and verification at our consolidation and fulfilment centers to ensure it meets our strict authenticity and quality standards before being shipped and delivered to you.
If you ever have concerns regarding the authenticity of a product purchased from us, please contact Bolo Support. We will review your inquiry promptly and, if necessary, provide documentation verifying authenticity or offer a suitable resolution.
Your trust is our top priority, and we are committed to maintaining transparency and integrity in every transaction.
All product information, images, descriptions, and reviews originate from the manufacturer or from trusted sellers overseas. BOLO is not affiliated with, endorsed by, or an authorized retailer for most brands listed on our website unless stated otherwise.
While we strive to display accurate information, variations in packaging, labeling, instructions, or formulation may occasionally occur due to regional differences or supplier updates. For detailed or manufacturer-specific information, please contact the brand directly or reach out to BOLO Support for assistance.
Unless otherwise stated, all prices displayed on the product page include applicable taxes and import duties.
BOLO operates in accordance with the laws and regulations of United Arab Emirates. Any items found to be restricted or prohibited for sale within the UAE will be cancelled prior to shipment. We take proactive measures to ensure that only products permitted for sale in United Arab Emirates are listed on our website.
All items are shipped by air, and any products classified as “Dangerous Goods (DG)” under IATA regulations will be removed from the order and cancelled.
All orders are processed manually, and we make every effort to process them promptly once confirmed. Products cancelled due to the above reasons will be permanently removed from listings across the website.
Description:
Editorial Reviews
About the Author
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.
Reviews:
5.0 out of 5 stars excellent resource
great book by Susan Needle.
Books look
Book should be published in colored pages.
Similar suggestions by Bolo
More from this brand
Similar items from “Biomedical Engineering”
Share with
Or share with link
https://www.bolo.ae/products/U103229163K