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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmacovigilance-masterclass-global-compliance-risk-mana/
课程评论：没有评论
**课程总结：药物警戒大师班 - 全球合规与风险管理** 本课程是您学习药物警戒（PV）和药品安全合规的终极指南。本课程专为医疗保健专业人士、法规事务专家、药剂师和药物警戒官员设计，提供与国际法规和当地实践接轨的深入、实践性培训。 您将探索不良事件报告、病例管理、药物警戒系统、风险管理计划、信号检测、CAPA（纠正和预防措施）流程以及审计。课程对比了欧盟、海湾合作委员会（GCC）和美国（FDA）的框架，并深入探讨了海湾地区当地药物警戒的挑战和策略。 课程特色包括： * **实践性内容：** 通过实际案例研究、测验、信息图、法规模板和全面的视频内容，确保您获得可操作的技能和知识。 * **前沿技术：** 探索人工智能信号检测等前沿药物警戒技术，并学习如何有效应对检查和召回。 * **全球视角：** 对比欧盟、GCC和美国（FDA）的框架，并专注于海湾地区的本地挑战和策略。 * **专家指导：** 由拥有10年以上在卡塔尔、巴林和欧盟监管事务经验的认证GDP、ISO和PV顾问Othman Abdallah授课。 * **职业发展：** 无论您是想提升职业生涯还是刚开始从事药物警戒工作，本课程都提供循序渐进的学习、全程支持、实用工具和真实的监管见解，助您取得成功。 本课程旨在为您提供药物警戒和全球法规合规领域的信心、认证和全球公认的专业知识，以支持您的职业发展和专业成功。
This course is your ultimate guide to Pharmacovigilance (PV) and drug safety compliance. Designed for healthcare professionals, regulatory affairs specialists, pharmacists, and PV officers, the course provides in-depth, practical training aligned with international regulations and local practices.You will explore adverse event reporting, case management, PV systems, risk management plans, signal detection, CAPA processes, and audits. The course compares frameworks across the EU, GCC, and the US (FDA), and dives into local PV challenges and strategies in the Gulf region.Real-world case studies, quizzes, infographics, regulatory templates, and comprehensive video content ensure you gain actionable skills and knowledge. You'll also explore cutting-edge PV technologies like AI-based signal detection and learn how to respond to inspections and recalls effectively.Led by Othman Abdallah, a certified GDP, ISO, and PV consultant with 10+ years in regulatory affairs across Qatar, Bahrain, and the EU, this course ensures you'll walk away with confidence, certification, and globally recognized expertise. Whether you're enhancing your career or starting in PV, this program offers step-by-step learning, full support, practical tools, and real regulatory insights to help you succeed.We sincerely hope this course will be beneficial in supporting your career growth and professional success in the field of pharmacovigilance and global regulatory compliance.
