CenterWatch publishes complete guide to global biopharmaceutical regulations
Boston, Mass., June 20, 2011—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 CenterWatch’s Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration.
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. Copies can also be purchased online at http://store.centerwatch.com along with CenterWatch’s entire Clinical Research Training Guide series. For volume discounts, contact firstname.lastname@example.org.
Founded in 1994, CenterWatch is a trusted source and global destination of clinical trials information for both professionals and patients. CenterWatch provides a wide variety of information services including grant leads for investigative sites; business development leads for contract service providers; postings of career opportunities; listings of clinical trials actively seeking patients; advertising and promotional opportunities; and proprietary business analysis and data about the global clinical trials industry. Visit www.centerwatch.com.
Cheryl Appel Rosenfeld