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所在平台: Udemy |
课程主页: https://www.udemy.com/course/usfda-electronic-submission-gateway/
课程评论：没有评论
课程名称：美国FDA电子提交网关工具（Regulatory Affairs US-FDA Electronic Submission Gateway tool） 课程概述： 本课程旨在帮助从事监管事务的专业人士掌握FDA电子提交网关（ESG）的相关知识。通过学习本课程，您将能够高效处理监管障碍，迅速获得注册产品的批准。FDA ESG是一个用于接收电子监管提交的机构级解决方案，它提供高效、可扩展且安全的环境，使FDA及其合作伙伴能够通过行业标准协议进行各种文件和提交的交换。 FDA ESG的优势包括： - 支持自动处理监管信息，并作为接收和处理所有电子提交的单一入口。 - 确保遵循安全的超文本传输协议（HTTP）消息标准，使用数字证书进行安全通信。 - 提供WebTrader（WT）和AS2两种提交方式，自2006年投入使用，每天由数百名用户发送数千份提交。 - 能够通过电子提交方式快速确认提交是否被FDA接收，减少传统邮寄的等待时间，提高效率。 课程收益： - 学习美国FDA ESG的基本知识和功能。 - 理解提交前的准备工作和注册流程概述。 - 掌握申请程序和账户创建。 - 了解用户访问信息和监管提交工具的使用。 适合人群： - 制药行业专业人士 - 监管事务助理 - 医药学硕士/本科生 - 药剂学硕士/本科生 - 有意从事监管事务职位的求职者 通过本课程的学习，您将能够提升自身在医疗器械注册提交方面的能力，利用FDA ESG节省时间并改善提交结果。
If you Regulatory affairs profession and you are not aware about ESG (Electronic Submission gateway, then this course will make you specialist in handling regulatory hurdles. You can easily get Approval for your registered product in less time.The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. The FDA ESG enables the FDA to process regulatory information automatically, functioning as a single point of entry for receiving and processing all electronic submissions in a highly secure environment. The FDA ESG complies with secure Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for secure communication. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing and notification (to a receiving Center or Office) of the delivery of an electronic submission.FDA ESG provides two methods, WebTrader (WT) and AS2, for making submissions to FDA. FDA ESG has been in production since 2006 and is used by 100s of users to send 1,000s of submissions every day.eMDR uses the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The FDA ESG (also referred to as the ESG or the Gateway):Enables the FDA to process regulatory submissions automaticallyFunctions as a single point of entry for the receipt and processing of all electronic submissions in a secureenvironment that complies with secure messaging standardsServes as a conduit, or "highway," along which submissions travel to reach their final FDA destinationAutomatically routes submissions to the appropriate FDA Center or Office.USE THE FDA ESG TO SAVE TIME & IMPROVE OUTCOME OF YOUR DEVICE SUBMISSIONOne of the biggest advantages of using the FDA ESG solution is how much time it can save you once you're ready for your device submission. You can confirm that your submission was received by FDA almost immediately and say goodbye to long wait times that come standard with snail mail.Of course, you still need to put the time into making a strong case for your device submission; and for that, you need a robust document management system that serves as a single source of truth for all information you'll need. This is often an area where medical device companies trip up in their submissions.Your submission could easily consist of years worth of documents, records, and activities. All of that information must be properly managed and kept in a secure, up-to-date system. The last thing you would want is for all of your hard work and progress to be in vain after using an efficient document management tool that let things fall through the cracks.One of the surest ways to improve the outcome of your device submission is by using a reliable eQMS to manage all of your documentation. Greenlight Guru is purpose-built for medical device companies and comes fully validated out-of-the-box with dedicated workflows, specifically, Document Management Software along with other workflows for every stage of the product lifecycle.Benefits of course:Introduction to USFDA ESGPreparation Activities for submissionOverview of registration processLearning of application procedureAccount creationUser access informationLearn Regulatory submission tool Eligibility for course:Any Pharma industry professionRegulatory affairs AssociateM. Pharmacy graduates/undergraduatesB. Pharmacy graduates/undergraduatesRegulatory affairs job seekers
