What we learned while making Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
RAPS recently released Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, a book (or e-book) that will serve as a one-stop reference that covers the entire drug lifecycle.
Consolidating the knowledge of more than 50 subject matter experts across 32 chapters, this book places all the laws, regulations, and guidances needed at your fingertips.
RAPS brought together several authors to get their views on why this resource is valuable for regulatory professionals and what they learned while making it.
Thanks again to our authors for all of their hard work bringing this important project together.
Tyler Vandivort, PhD, RAC-Drugs, DABT, director of regulatory affairs and operations at Amplicore
What a reader will get out of this book: The right perspective. RAPS’ textbooks are written by regulatory affairs professionals, for regulatory affairs professionals. While other resources often either glaze over essential points, or leave the reader hopelessly lost in the minutiae of a topic, these chapters are utilitarian by design—presenting important global concepts in simplified language intended to help busy professionals navigate the many niche areas of their field as they seek to respond to new daily challenges.
What I learned: The long-awaited first revision to the S1B guidance, “Testing for Carcinogenicity of Pharmaceuticals,” was adopted by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in August 2022. This document outlines an innovative process by which sponsors perform a weight of evidence assessment to determine whether the standard, two-year rodent bioassay for carcinogenicity is likely to provide value for a development program (or can be entirely omitted). As this guidance continues to be implemented worldwide, I was very excited to pour through it myself for the first time, and to condense this information into a quality overview for readers.
Marjorie Zettler, PhD, MPH, executive director of clinical science at Regor Therapuetics Group
What a reader will get out of this book: This book has a wealth of up-to-date information on drug development worldwide, delivered by experts with first-hand experience. More than a simple review of regulations, this book also provides context for interpretation from people actually working in the field.
This new book in the Fundamentals series updates and expands earlier versions to provide a comprehensive, global view of pharmaceutical and biologic regulations. One of the new chapters, which my co-author and I wrote, is about regional-specific studies, a topic not covered in previous editions of this book. This chapter explores some of the challenges of global drug development and how well-planned and executed multi-regional clinical trials can be an efficient approach.
What I learned: I realized what a tremendous increase there’s been in recent years in the number of scientific articles and perspectives published about regulatory issues, authored by both industry leaders and by regulators. This information is so important because when these authors share their experiences and their insights, we can all learn from them and apply that valuable information to the drugs that we’re developing now or will develop in the future.
Amrita Ghosh, senior clinical researcher and regulatory lead at Stanford Radiology
What a reader will get out of this book: To have one place for all the global pharmaceutical and biologics laws, regulations, and guidance will be an amazing resource for the readers to grow their professional and personal knowledge in regulatory affairs.
What I learned: The global approach was something challenging for all of my team members. As a lead author, I have US drugs and biologics regulatory experience and my other team members had Latin America and EU experience. We authored Chapter 22 on eCTD and Digitial Applications. Gathering all the global regulations and changes in eCTD was daunting as this is a new regulation in many countries, but we learned a lot about global regulations in the process.
Yuwei Zhang, director, innovative analytics/data strategy/clinical trial innovation at Parexel
What a reader will get out of this book: If you're passionate about understanding the latest regulation changes, fundamental processes, and frameworks involved in drug development, then you’ll want to pick up this book. By comparing and contrasting different approaches, this book offers a comprehensive overview of the drug development landscape and sheds light on the challenges and opportunities.
What I learned: I have gained a better understanding of the policy differences in approvals among different countries, as well as the reasons behind these differences due to each country's unique circumstances and priorities.
Siegfried Schmitt, vice president, technical at Parexel
What a reader will get out of this book: It is the reference book. The succinct explanations and discussions of the regulations and the unrivalled number of citations makes this essential reading, for reference and education purposes, and for pure reading pleasure.
What I learned: Covering and interpreting the regulations for the entire lifecycle of a pharmaceutical or biological product is only possible with the help of a global network of regulatory professionals, who are willing to share their eminent knowledge and insight. Very gladly, RAPS has just this network.
Timothy Candy, principal consultant at Opus Regulatory
What a reader will get out of this book: Given all the experts who have dedicated their energy into writing their respective chapters, this book could be the greatest compilation of fundamental regulatory knowledge to exist in one central resource. At minimum, it will serve anyone needing a good starting point for any given regulatory discipline and to further inform the reader on where else they can read up in more detail if they so choose to.
What I learned: How difficult it is for someone to condense and consolidate all the knowledge gained over the years of a regulatory career down into one succinct chapter.
Ruchi Gupta, program director, regulatory affairs at Genentech
What a reader will get out of this book: Whether you are a regulatory affairs professional or in any other field associated with drug development, this book is full of country specific drug and biologics regulations and guidances saving one's time and energy to search for information that is compiled by the experts in this field.
What I learned: I learned that the health authorities across the globe work with the single objective of creating provisions around access of timely and efficacious treatments ensuring patients' safety at the same time.
Parvarsha Nafees, senior associate manager, regulatory affairs at Martin Dow Limited
What a reader will get out of this book: This book outlines all aspects of pharmaceutical and biologics development from the very beginning of clinical trials until the marketing authorization and even after the postmarketing authorization.
What I learned: The chapter I worked on was Chapter 32: Market Access: Reimbursement and Pricing. While I was working on this chapter, I realized there was so much more to this little aspect of regulatory affairs than what I already knew. I really enjoyed working on this chapter. It reshaped my thinking about the policies, the frameworks and guidelines, and it helped me critically analyze the policies that are already prevailing in my own country.
Ajay Babu Pazhayattil, independent consultant, cGMP World
What a reader will get out of this book: When we started off, the editorial team was very particular in making sure that the chapters in the textbook should be global in nature. So that was one of the challenges we had, was to bring all of the global regulations in one place. And I think that’s one thing that a reader will get from this book.
What I learned: We worked on Chapter 12: Coordinating Drug Supply for Clinical and Nonclinical Development , and when we looked into the literature that was available, the one thing that struck us was that there’s nothing much out there. That actually excited us in a way. This chapter was something we wanted to create for the benefit of the community.
Katelyn Mulligan, senior submission manager at Bristol Myers Squibb
The reader will get a current pulse check on the ever-changing world of regulatory affairs. Change is inevitable in many things in life, but it’s certainly happening all the time in the pharmaceutical industry. This book is great at giving a framework for all the different aspects of the industry and what’s currently happening.
What I learned: Working with the two other folks on my chapter, it was interesting learning about their backgrounds. One of us is in academia, I’m in industry, so just getting a broader understanding of just how far-reaching regulatory affairs is.
Robert Falcone, senior manager, regulatory affairs at Prestige Consumer Healthcare
What a reader will get out of this book: The beauty of this particular edition is that we added new topics, new areas that people never thought about but worked with. We need to think, as regulatory professionals, in a global perspective. The information the book provides is for that purpose: to help the regulatory professional strategize better, not only in the US but all over the world.
What I learned: It’s interesting to see how much the regulations have changed, because we do take it for granted. Because we work day-in, day-out without realizing some of the changes. Not only in the US, because that’s a place we feel is always changing; but for instance to give an example, how much China has actually changed.
Long gone are the days that you only think about one country or one entity.
Mantej Chhina, PhD, JD, RAC, executive director, head of global R&D and regulatory policy at Biomarin Pharmaceutical
What a reader will get out of this book: The most current global perspective on drug and biologic development from a regulatory perspective all in one place to support and inform global development programs.
What I learned: In my research for Chapter 28: Compliance, I experienced the breadth and complexity of the global regulatory environment (!) and realized the tremendous value in efforts like this one to collate and summarize useful information in a coherent manner.
Anne Marie Woodland, MS, senior vice president, regulatory affairs at Beam Therapeutics
What a reader will get out of this book: A perspective on how different countries and regions approach pharmaceutical and biologics regulations. It’s a comprehensive view of the regulations and practices on a global perspective. It gives good insight and a place to look for information when working globally.
What I learned: I learned more about the regulations in the Middle East. It’s not an area I have typically worked and found it was similar to EU and US.
Stefanie Fasshauer, MBA, head of regulatory affairs, APAC at PharmaLex
What a reader will get out of this book: The book provides a comprehensive and up-to-date understanding of the pharmaceutical and biologic regulatory landscape, addressing essential facets of the industry from a global perspective. It provides readers with useful insights and recommendations to help them manage the complex regulatory environment and make informed decisions.
What I learned: I gained knowledge regarding the constantly changing regulatory environment and the difficulties that several companies encounter while striving to comply with the revised regulations for pharmaceutical and biologics products. The book emphasized the significance of cooperation between regulatory agencies, industry stakeholders, and other significant players to guarantee patient safety and the accessibility of effective treatments.
Darlene Rosario, MBA, RAC-Drugs, senior vice president of regulatory affairs, quality and medical writing at CytomX Therapeutics
What a reader will get out of this book: A new regulatory professional can use this book as a valuable resource since many people with years of experience have come together to provide insight, knowledge and expertise to each topic. It’s not just book knowledge. It is real-world experience.
What I learned: With all the years of experience I have, there is still much to learn.
Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global, founder and consultant at Synergy Global Regulatory Affairs Consultancy
What a reader will get out of this book: This book is a comprehensive global regulations compilation which is an excellent resource and a practical reference handbook in pharmaceuticals and biologics regulations, for regulatory professionals both academia and industry.
What I learned: I contributed to Chapter 3: International Harmonization via ICH, WHO, and other Global Initiatives and Chapter 32: Market Access—Reimbursement and Pricing, which covered diverse topics and required conducting intensive research. As an author, my focus was on capturing the latest global regulatory information and learning to apply new approaches for condensing the information to allow readers to grasp the knowledge from these chapters effortlessly.
Bayan A. Arar, healthcare and life sciences consultant
What a reader will get out of this book: The global scheme of the healthcare landscape. This comprehensive book on drugs and biologics provides unique content for the global regulatory community supporting industry professionals, health authority personnel, and academia through their day-to-day key tasks; implementing practical strategies.
Given the context of medicinal product development and health authority oversight, readers will find a lot of interesting insights combined with in-depth content through expanded chapters to cover the entire lifecycle from preclinical to market access.
What I learned: It was interesting to see and outline key milestones achieved from preclinical to post-market surveillance, focusing on key existing and ongoing harmonization efforts, and highlighting the effect of digitalization towards the globalization of key markets.
The healthcare industry has truly become global in nature combined with a necessity to reach win-win outcomes for all concerned stakeholders partnering with patients early from the drug development process to satisfy their needs with value-added therapies.
Kholoud Mamdouh, MSc, technical support unit manager at Clinical Trials General Directorate, Egyptian Drug Authority
What a reader will get out of this book: It is challenging to provide professionals in this field with a single source of information for pharmaceutical regulatory affairs because working in this field necessitates an understanding of national and regional frameworks, requirements, and scientific viewpoints. This book is highly recommended as a handbook for regulatory affairs professionals seeking multicountry submissions and creating business plans.
What I learned: I learned a lot in contributing to Chapter 24: Dossier Requirements. I was able to gain endless details on dossier requirements while working on this project as I gathered laws, regulations, and guidelines related to different aspects of the dossier requirements, writing them down, and compared them across the globe.
Nikolaos Zacharias, MSc, senior CMC regulatory affairs project manager
What a reader will get out of this book: The opportunity to obtain a consolidated and comprehensive knowledge of the global pharmaceutical and biologics regulations and to emphasize at various aspects covering the development, registration, market access and lifecycle management of medicines.
What I learned: I would say that I appreciated even more the importance and value of sharing experience and knowledge through this contribution with others.
Leonor Pessanha Saldanha, principal regulatory affairs specialist - clinical research at PPD
What a reader will get out of this book: If someone buys this book, they will see a big-picture review on the main fundamental regulatory topics about drugs and biologics. And contributors are regulatory experts from well-known, successful companies, so you can expect a book authored by the best regulatory professionals in the industry.
What I learned: While getting engaged in authoring Chapter 17: Enhancing Diversity in Clinical Trials, I learned a lot about it because I was engaged with other co-authors with different experiences because they were from other regions in the world. This is why I think it’s worth it to buy the book. Because in every chapter there’s something to learn that adds experience and expertise.