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ISBN-13:9783319175898
Book Title:Pharmaceutical Regulatory Environment
Number of Pages:Xiii, 236 Pages
Language:English
Publication Name:Pharmaceutical Regulatory Environment : Challenges and Opportunities in the Gulf Region
Publisher:Springer International Publishing A&G
Publication Year:2015
Subject:Public Health,Internal Medicine
Item Weight:177.4 Oz
Type:Textbook
Item Length:9.3 in
Subject Area:Medical
Author:Sam Salek,Reem K. Al-Essa,Stuart Walker,Mohammed Al-Rubaie
Item Width:6.1 in
Format:Hardcover
Pharmaceutical Regulatory Environment by Stuart Walker, Sam Salek, Reem K. Al-Essa, Mohammed Al-Rubaie Estimated delivery 3-12 business days Format Hardcover Condition Brand New Description This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients access to new medicines.The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region.Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region. Author Biography Reem Al-Essa BPharm MSc PhD was the Drug Registration and Release Superintendent for six years of her 12 years experience with Ministry of Health, Kuwait. During this period she completed her MBA with distinction. She later undertook the EU2P MSc in Pharmacovigilance and Pharmacoepidemiology. Dr Al-Essa has published six journal articles and abstracts related to pharmaceutical regulation in the Gulf region.Mohammed Hamdan Al-Rubaie BPharm MSc PhD is the Director of Drug Control, Directorate General of Pharmaceutical affairs and Drug Control, Oman Ministry of Health.He is a member of the GCC Central Registration Committee, and actively involved in many other GCC committees and working groups for the drafting of the GCC pharmaceutical regulations and policies. Dr Al-Rubaie was instrumental in forming the Pharmaceutical society in Oman and chaired it from 2010-2011.Stuart Walker BSc, PhD, MFPM FRSC FIBiol, FRCPath, is the Founder of the Centre for Medicines Research International, the Centre for Innovation in Regulatory Science and Professor of Pharmaceutical Medicine, University of Wales, Cardiff. During his research career in academia & industry, he has supervised many PhD programmes in clinical development, regulatory policies, the benefit/risk assessment of medicines and health technology assessment, co-authored 280 research papers and edited 25 books. He is frequently involved in the organisation of international meetings on key issues that concern the regulatory review of medicines and has lectured extensively throughout Europe, the USA, the Asia-Pacific Region, Latin America and the Middle East.Sam Salek PhD RPh FFPM MRPSGB MCMS FESCP is Professor of Pharmacoepidemiology at the University of Hertfordshire, Hatfield, visiting Professor at the Estate of Hessen, Germany, and Director of the Institute for Medicines Development, Cardiff, UK. Professor Saleks research focuses mainly on four areas: development and application of patient-reported outcome measures; drug safety evaluation and pharmacovigilance; pharmacoeconomics and economic evaluation of healthcare; and pharmaceutical regulation & medicines development in the mature and emerging markets. He has published 19 books and 600 journal articles and abstracts. Professor Salek is a member of five Editorial Boards and an active member of several societies. Details ISBN 3319175890 ISBN-13 9783319175898 Title Pharmaceutical Regulatory Environment Author Stuart Walker, Sam Salek, Reem K. Al-Essa, Mohammed Al-Rubaie Format Hardcover Year 2015 Pages 236 Edition 2015th Publisher Springer International Publishing AG GE_Item_ID:137888181; About Us Grand Eagle Retail is the ideal place for all your shopping needs! With fast shipping, low prices, friendly service and over 1,000,000 in stock items – you’re bound to find what you want, at a price you’ll love! 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