{"product_id":"global-regulatory-inspections-in-clinical-essam-abdelhakim-9798305549508","title":"Global Regulatory Inspections in Clinical Research: Preparation, Response, and Lessons Learned","description":"\u003cp\u003eThis comprehensive guide explores the critical role of \u003cb\u003eregulatory inspections\u003c\/b\u003e in clinical research, offering a global perspective on the processes and expectations of key regulatory authorities. \u003ci\u003eThe book\u003c\/i\u003e covers the history, mandates, and inspection methodologies of major bodies such as the FDA, EMA, MHRA, PMDA, Health Canada, TGA, SFDA, and DCGI, while highlighting common findings and strategies to address them effectively.\u003c\/p\u003e\u003cp\u003eReaders will gain practical insights into preparing for inspections, managing noncompliance, and crafting robust Corrective and \u003cb\u003ePreventive Action (CAPA) plans\u003c\/b\u003e. Through detailed case studies and lessons learned, the book illustrates real-world scenarios and actionable strategies for sites, sponsors, and CROs to enhance their readiness and practices.\u003c\/p\u003e\u003cp\u003eThe book also delves into global trends, including the increased focus on electronic data, decentralized trials, and harmonization efforts under ICH-GCP. With a focus on quality systems and leveraging technology, it provides long-term strategies to maintain compliance and improve trial outcomes.\u003c\/p\u003e\u003cp\u003e\u003ci\u003eIdeal for clinical research professionals\u003c\/i\u003e, this guide equips readers with the tools to navigate inspections confidently and uphold the highest standards in clinical research.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Essam Abdelhakim\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798305549508\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Independently Published\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 01\/01\/2025\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 48\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.17lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.10d","brand":"Essam Abdelhakim","offers":[{"title":"Paperback","offer_id":48137061171455,"sku":"9798305549508","price":7.9,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_2305e0be-2296-440c-8169-e3868c88a81d.jpg?v=1770166266","url":"https:\/\/www.whiterainbookhouse.com\/products\/global-regulatory-inspections-in-clinical-essam-abdelhakim-9798305549508","provider":"WR Book House","version":"1.0","type":"link"}