Written by Dr. Henrietta N. Ukwu, M.D., FACP, FRAPS, senior vice president and head of global regulatory affairs for Pharmaceutical Product Development, Inc. (PPD) and adjunct professor at the Graduate School of Pharmacy at Temple University, this new book is the only current reference guide to navigate the dynamic landscape of all the major global biopharmaceutical regulatory agencies and consolidate the most pertinent and relevant facts and guidelines into one resource.

"[Global Regulatory Systems] provides an insightful perspective and breadth of experience on the worldwide regulatory systems that are critical to the success of clinical trials management," said Emilio Emini, Ph.D., chief scientific officer of vaccine research at Pfizer. "It is an expansive and unparalleled manual for regulatory professionals that describes and helps navigate the complex and ever-changing global regulatory processes."

This 336-page text book includes a breakdown of the regulatory systems of the world’s major markets, plus emerging markets in Latin America, the Middle East, Africa and Central and Eastern Europe; a frame work for approaching each system; comparisons of various countries’ agencies and a thorough analysis of regulatory roles and processes. It also offers effective strategies, suggested exercises and 200 charts and graphs.

"Early reactions to the new book have been extremely positive," said Joan Chambers, COO of CenterWatch. "Professionals have been trying to manage complexities and challenges that accompany conducting clinical trials in ever more dispersed and remote markets around the world. With valuable global regulatory information and insights in one place, we expect the book to quickly become a frequently referenced must-have resource."

Global Regulatory Systems will be available at DIA’s 47th Annual Meeting being held in Chicago this week.