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所在平台: Udemy |
课程主页: https://www.udemy.com/course/us-regulatory-strategy-for-biologics-pharmaceutical-drugs/
课程评论：没有评论
课程名称：美国生物制剂和药品的监管策略 课程概述：了解、应对和遵循美国食品和药物管理局（FDA）的法规，对于将医疗发现从实验室转化到临床应用至关重要。在本课程中，我们将探讨法规对公共健康的重要性，如何通过FDA的法规，成功将生物制剂或药品推向市场，并实践制定监管策略。在课程结束时，学员将全面理解药物开发过程，并学习获得FDA批准的关键监管步骤。掌握这些知识后，学员将提升进行监管情报分析和制定监管战略计划的能力。科学家、医生、企业家、公共卫生专业人士、行业分析师、顾问及对生物技术和制药行业感兴趣的生物医学学生均可从该课程中受益。
Understanding, navigating, and complying with the United States Food & Drug Administration (FDA)'s regulations is vital to translating medical discoveries from "bench to bedside". In this course, we will explore why regulations are important for public health, how to navigate through the FDA regulations to market a biologic or pharmaceutical, and practice developing a regulatory strategy. At the end of this course, we will understand the drug development process and learn the key regulatory steps toward FDA approval. With this knowledge, we will also develop our ability to conduct regulatory intelligence and develop a regulatory strategic plan. Scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry may find this course valuable.
