@article{726978,
      recid = {726978},
      author = {Al-Essa, Reem K., and Al-Rubaie, Mohammed, and Walker,  Stuart, and Salek, Sam,},
      title = {Pharmaceutical regulatory environment challenges and  opportunities in the Gulf Region / [electronic resource] :},
      pages = {1 online resource},
      abstract = {The Middle East 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. 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. Pharmaceutical Regulatory Environment:  Challenges & Opportunities in the Gulf Region is a must  read for those interested in pharmaceutical regulation in  the Gulf region. Reem Al-Essa BPharm MSc PhD was the Drug  Registration and Release Superintendent, Kuwait Ministry of  Health, Drug and Food Control Department, for 12 years  during which time 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 Salek?s 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.},
      url = {http://library.usi.edu/record/726978},
      doi = {https://doi.org/10.1007/978-3-319-17590-4},
}