Develop your understanding of the regulatory landscape in Latin America to ensure fast device registration
Course Overview
随着拉丁美洲的医疗器械市场估计值为110亿美元，增长，监管专业人员必须了解当地法规和快速市场准入的要求。该课程从国家到国家的国家，从档案准备和分类到生命周期管理和标签，探讨了拉丁美洲的关键问题，因此您拥有所需的技能来获得您的设备批准。
作为well as learning about the fundamentals of local regulations the course will also develop best practiced strategies to manage important relationships and import your devices, which can cause significant problems if overlooked.
主要重点：巴西，墨西哥和阿根廷
还讨论了：哥伦比亚，委内瑞拉，智利，秘鲁，厄瓜多尔，巴拉圭和哥斯达黎加
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.
Over 2 days students will learn through:
- 现场互动一口体积会话
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- 与在场会议期间和在线论坛的对等人互动
时间和日期可能会进行更改 - 将提供登录详细信息的最终确认。代表将在课程开始日期的一周内收到登录说明。如果您有任何疑问，请联系lifesciences-training@informa.com..
你会学到什么？
Existing mutual recognition agreements
Existing mutual recognition agreements
Discover mutual recognition agreements and harmonisation in the region for a simplified approval process in multiple countries
Dossier requirements
Dossier requirements
Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices
关键发展
关键发展
Learn about future regulatory developments in the region
Lifecycle management
Lifecycle management
Examine lifecycle management, such as variation and renewal procedures to effectively manage your device post approval
ANVISA GMP审计
ANVISA GMP审计
探索Anvisa GMP审核和IMDRF方案来消除这种冗长的程序
形成当地伙伴关系
形成当地伙伴关系
Understand the importance of having local contacts in the region and evaluate the ‘pros’ and ‘cons’ of using distributors and host companies
Who is this course for?
This course has been designed for experienced regulatory professionals who are either new to operations in Latin America or are already working in the region and want to further increase their knowledge.
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
我们的现场上在线学院的代表说......
94%
97％
97％
Routledge书籍25％的折扣
作为a student on the course, you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge websitewww.routledge.com..
Examples of books and eBooks within medical devices include:
- 医疗设备质量保证和监管合规性
- 医疗器械和设备：原则和实践
- Design Controls for the Medical Device Industry, Third Edition
- Medical Device Regulatory Practices: An International Perspective
- Handbook of Medical Device Regulatory Affairs in Asia: Second Edition
- And more
