v
Introduction
T
he first question we asked ourselves when the idea came up for this book was: Does the regulatory community really need it?
The answer was an unequivocal “yes,” and here is why. We are both of an age at which chats with friends and family revolve around
ailments and medication more often than we would like to admit. And, as healthcare industry professionals, we are often asked
probing questions such as whether a vaccine really has as many side effects as the label says why a drug costs so much or why it has taken
so long to develop an Alzheimer’s drug.
Of course, this book is not written for our friends and family members, but really for the regulatory professionals who need to have the
answers to such questions.
So where do we find the answers? Sadly, the information is all over the place – there is an article here, a book chapter there. Some
are in Chinese some are in English and others in yet another language. There was no single, comprehensive source for a global regulatory
perspective on drugs and biologics.
And that is why this book is an absolute necessity for regulatory professionals globally. Does it give you the answers to all and every-
thing? That would be wishful thinking. It does, however, give you, dear reader, the single best source of authoritative regulatory information
and guidance that our collaborative of more than 50 global expert authors and we, as editors, can bring you.
We sincerely hope you will enjoy reading it and glean helpful bits of information that answer your questions – and maybe even those of
your families and friends. And if you have a minute, do let us know your feedback.
Linda McBride, RPh, RAC-US
Partner, IAA Consulting LLC
Linda McBride, RPh, RAC-Drugs, is a partner at IAA Consulting with
extensive experience in the science of drug development in the biopharma-
ceutical industry. Over her career of more than 30 years, she has had direct
experience in developing and implementing registration strategies for
pharmaceuticals and biologics in various therapeutic areas, from candidate
selection through marketing application and postapproval. McBride has
significant expertise in preparing teams for successful interactions with
health authorities and for delivering approvals for marketing applications
for pharmaceutical and biological products while striving to achieve the
corporate vision for success. She is a RAPS member and serves on its Edi-
torial Advisory Committee and the Convergence Planning Committee.
Siegfried Schmitt, PhD
Vice President Technical, Parexel Consulting
Siegfried Schmitt, PhD, has been Vice President Technical in the Strategic
Compliance Consulting group of Parexel International since 2007. He has
more than 30 years of experience and expertise in the global pharmaceutical
and medical device industries. He provides consulting services to customers
in the healthcare industry on all aspects of regulatory compliance, particular-
ly in the design and implementation of effective and efficient quality man-
agement systems. The services cover the entire product lifecycle, from the
clinical to the commercial phase. Schmitt serves on several editorial advisory
committees, has written or contributed to 28 books, and has published well
over a hundred articles for renowned journals, including RAPS Regulatory
Focus. He has been a member of RAPS since 2010, serves on its Editorial
Advisory Committee, and as co-chair of Euro Convergence 2023.
Introduction
T
he first question we asked ourselves when the idea came up for this book was: Does the regulatory community really need it?
The answer was an unequivocal “yes,” and here is why. We are both of an age at which chats with friends and family revolve around
ailments and medication more often than we would like to admit. And, as healthcare industry professionals, we are often asked
probing questions such as whether a vaccine really has as many side effects as the label says why a drug costs so much or why it has taken
so long to develop an Alzheimer’s drug.
Of course, this book is not written for our friends and family members, but really for the regulatory professionals who need to have the
answers to such questions.
So where do we find the answers? Sadly, the information is all over the place – there is an article here, a book chapter there. Some
are in Chinese some are in English and others in yet another language. There was no single, comprehensive source for a global regulatory
perspective on drugs and biologics.
And that is why this book is an absolute necessity for regulatory professionals globally. Does it give you the answers to all and every-
thing? That would be wishful thinking. It does, however, give you, dear reader, the single best source of authoritative regulatory information
and guidance that our collaborative of more than 50 global expert authors and we, as editors, can bring you.
We sincerely hope you will enjoy reading it and glean helpful bits of information that answer your questions – and maybe even those of
your families and friends. And if you have a minute, do let us know your feedback.
Linda McBride, RPh, RAC-US
Partner, IAA Consulting LLC
Linda McBride, RPh, RAC-Drugs, is a partner at IAA Consulting with
extensive experience in the science of drug development in the biopharma-
ceutical industry. Over her career of more than 30 years, she has had direct
experience in developing and implementing registration strategies for
pharmaceuticals and biologics in various therapeutic areas, from candidate
selection through marketing application and postapproval. McBride has
significant expertise in preparing teams for successful interactions with
health authorities and for delivering approvals for marketing applications
for pharmaceutical and biological products while striving to achieve the
corporate vision for success. She is a RAPS member and serves on its Edi-
torial Advisory Committee and the Convergence Planning Committee.
Siegfried Schmitt, PhD
Vice President Technical, Parexel Consulting
Siegfried Schmitt, PhD, has been Vice President Technical in the Strategic
Compliance Consulting group of Parexel International since 2007. He has
more than 30 years of experience and expertise in the global pharmaceutical
and medical device industries. He provides consulting services to customers
in the healthcare industry on all aspects of regulatory compliance, particular-
ly in the design and implementation of effective and efficient quality man-
agement systems. The services cover the entire product lifecycle, from the
clinical to the commercial phase. Schmitt serves on several editorial advisory
committees, has written or contributed to 28 books, and has published well
over a hundred articles for renowned journals, including RAPS Regulatory
Focus. He has been a member of RAPS since 2010, serves on its Editorial
Advisory Committee, and as co-chair of Euro Convergence 2023.