Pharmaceutical Regulatory Environment (PDF)
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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.
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
- Autoren: Reem K. Al-Essa , Mohammed Al-Rubaie , Stuart Walker , Sam Salek
- 2015, 2015, 236 Seiten, Englisch
- Verlag: Springer-Verlag GmbH
- ISBN-10: 3319175904
- ISBN-13: 9783319175904
- Erscheinungsdatum: 06.05.2015
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- Größe: 7.16 MB
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