Regulatory and clinical professionals, professors and students now have a comprehensive guide to the complexities of drug approval and regulation around the world, with the first edition release of a new book by ANPA member, Dr. Henrietta Ukwu. The book, Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration is published by CenterWatch, a leading publisher for clinical research professionals.
Dr. Ukwu, a professor at the Temple University Graduate School of Pharmacy in Ambler, PA, is a Nigerian-born physician. She earned her medical degree from the University of Jos Faculty of Medical Sciences in Nigeria and then completed a residency in internal medicine at Baptist Hospital in Nashville, TN and a fellowship in infectious diseases at Vanderbilt University. She is a Fellow of the American College of Physicians (FACP) and the Regulatory Affairs Professional Society (FRAPS).
During her remarkable career in the pharmaceutical industry Dr. Ukwu has been Vice President and Head of Vaccine Regulatory Worldwide Regulatory Affairs at Merck, Vice President, Global Regulatory Affairs at Wyett, and in 2010, she was named Senior Vice President of Global Regulatory Affairs at PPD Inc.
Her book has been described by Jethro Ekuta, Vice President, Global Regulatory Affairs at Genzyme Corporation, as “a masterpiece for the history books and one that is poised to make her life-long vision of radically transforming the regulatory affairs profession into a truly strategic profession a reality!”. Dr. Ekuta, who described himself as one of Dr. Ukwu’s countless proteges, said that the book is written in a plain language that will appeal to all who seek to understand the regulatory systems in every region of the globe and on all therapeutic platforms (drugs, biologics and vaccines) and who seek to develop and register products globally.
Another strong endorsement came from Dr. Emilio A. Emini, Chief Scientific Officer, Vaccine Research at Pfizer. He described the book as “an expansive and unparalleled manual for regulatory professionals that describes and helps navigate the complex and ever-changing global regulatory processes.”
Dr. Ukwu is married to Dr. Isaac Ukwu and they are blessed with three children, Victor, Yvonne, Henry.
The book is available here.