Postapproval Changes for Drugs: A Practical Guide (e-book)
Table of Contents
Section I: Marketing Authorization Transfers, Renewals, and Administrative Changes
Chapter 1: United States
Chapter 2: Argentina, Brazil, Canada, Chile, and Mexico
Chapter 3: European Union, United Kingdom, and Switzerland
Chapter 4: Australia, New Zealand, Malaysia, and Singapore
Chapter 5: Middle East North Africa
Section II: Quality/Chemistry, Manufacturing, and Control Changes
Chapter 6: Argentina, Brazil, Canada, Chile, Mexico, and United States
Chapter 7: European Union, United Kingdom, and Switzerland
Chapter 8: Australia, New Zealand, Malaysia, and Singapore
Chapter 9: Japan
Section III: Safety and Product Information-Related Changes
Chapter 10: Argentina, Brazil, Canada, Chile, Mexico, and United States
Chapter 11: European Union, United Kingdom, and Switzerland
Chapter 12: China
Chapter 13: Middle East North Africa
Chapter 14: Africa
Section IV: Postauthorization Commitments and Studies
Chapter 15: Argentina, Brazil, Canada, Chile, Mexico, and United States
Chapter 16: European Union, United Kingdom, and Switzerland
Chapter 17: China
Chapter 18: Middle East North Africa
Chapter 19: Africa
Section V: Postmarketing Surveillance and Risk Management
Chapter 20: Argentina, Brazil, Canada, Chile, Mexico, and United States
Chapter 21: European Union, United Kingdom, and Switzerland
Chapter 22: Africa
Linda McBride, RPh, RAC-US and Pallavi Trivedi, MPH, RAC-US, editors
About the Book
Available formats: e-book only
Postapproval changes are a vital part of medicines development and regulatory affairs and reflect the dynamic and iterative nature of science and how products develop and mature across the lifecycle. RAPS new book, Postapproval Changes for Drugs: A Practical Guide, illustrates the breadth of this complex topic including key aspects of marketing authorization transfers, renewals, and administrative changes; quality and CMC changes; safety and product information-related changes; postauthorization commitments and studies; and postmarketing surveillance and risk management.
In each of the 22 chapters, expert authors take a comprehensive global look at the differences between the Americas, Europe, Asia, Middle East and North Africa (MENA), and sub-Saharan Africa. Postapproval Changes for Drugs is organized into five distinct sections according to the type of change being implemented. Each section covers various countries, including Africa, Argentina, Australia, Brazil, Canada, Chile, Malaysia, Mexico, New Zealand, Singapore, Switzerland, UK, and the US—the breadth of countries and regions never before covered in one single RAPS resource.
Postapproval Changes for Drugs includes the regulatory requirements, application of the requirements, and case studies with real-life scenarios and industry best practice. This new resource also includes a comprehensive glossary of terms, acronyms, and abbreviations, in addition to an in-depth index to help navigate through this complex regulatory landscape. Postapproval Changes for Drugs describes the regulations, tools, and pathways regulatory professionals need to remain compliant for changes after the initial approval. This valuable, must have resource will benefit all who participate in the commercialization of drugs and biological products.
Who will benefit from this book?
Postapproval Changes for Drugs was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework, including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant postapproval change regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions and promote collaboration on the necessary updates and changes that occur after initial marketing application approval to support the continued availability of new therapies to diagnose, prevent, treat, and cure diseases worldwide.
Postapproval changes are a vital part of medicines development and regulatory affairs, and RAPS new book covers the breadth of issues which encompass postapproval changes, ranging from marketing authorization transfers, administrative changes, late phase renewals through to additional indications. From a comprehensive global perspective, this book illustrates the differences between the Americas, Europe, Asia, Middle East and North Africa (MENA), and sub-Saharan Africa.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2022. E-book. 288 pages. ISBN (digital): 978-1-947493-81-0.
