"This informative, organized and well written text could be the new primer for the
global regulatory environment. It should be on the bookshelf of every product development
CEO, Halloran Consulting Group
"Global Regulatory Systems is the first book to outline concisely the criteria
regulatory agencies have established for drug approvals on a global basis. Professionals
in pharma, biotech, CROs and academia will benefit from this book by learning how to ‘work’
with various global regulatory agencies to understand their timelines, guidelines and
specific regulatory requirements in place for new drug development. Global Regulatory
Systems is a book from which companies will learn upfront what agencies require in order
to give them insight to develop drugs based on specific agency’s regulatory guidelines."
—Robert R. Ruffolo, Jr., Ph.D., D.Sc., D.Eng.
Retired President, Research & Development
"Dr. Henrietta Ukwu provides an insightful perspective and breadth of
experience on the worldwide regulatory systems that are critical to the success of clinical
trials management. Global Regulatory Systems is an expansive and unparalleled manual for
regulatory professionals that describes and helps navigate the complex and ever-changing
global regulatory processes."
—Emilio A. Emini, Ph.D.
Chief Scientific Officer, Vaccine Research
"Regulatory professionals are routinely asked a variant of the "can we do
this?" question. The task of answering this is nearly impossible without an understanding
of global regulatory guidance and practices. Therefore, it is essential that every
regulatory professional is armed with a framework for reference.
Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and
Registration provides a broad, yet concise and detailed, summary of the major
regulatory topics that invariably shape drug development programs, both operationally and
Managing Director, Halloran Consulting Group
"The Global Regulatory Systems book explores the complex global regulatory
environment in the clinical trials industry in a systematic and structured manner.
The graphs and tables compare and contrast the regulatory requirements of this dynamic
landscape. The book is a compilation of the author’s passion for the subject, working
knowledge, extensive experience and expertise for professionals and students to gain a
better appreciation of the similarities and differences in regulations between various
Temple University, MS QARA Program Student
Read a review by Norm Goldfarb,
Managing Director of First Clinical Research.
CenterWatch introduces the most concise, yet comprehensive resource available on the major global regulatory systems—including the most relevant and pertinent regulatory facts and guidelines—consolidated into one, must-have and easy-to-read resource. This strategic roadmap takes the reader through a dynamic and complex landscape while providing a fundamental understanding and application of global regulatory principles to ensure successful product development and registration.
- A breakdown of the major global regulatory systems and processes
- A framework for approaching each system
- Comparisons and contrasts of various regulatory agencies
- A thorough analysis of regulatory roles and processes
- Effective strategies for immediate development and implementation
- Suggested exercises that challenge the reader
- Nearly 200 charts and graphs
- Emerging markets including: Latin America, Central and Eastern Europe, Middle East and Africa
- New and current regulatory professionals from pharma, biotech, CROs
- Product development and project managers
- Undergraduate and graduate students
- Professors of Regulatory Affairs
- Academic researchers and investigators
- Financial analysts