“EUA和510k的成功诀窍”讲座
讲座时间：12/21 周三
中国时间:? ?9:00PM
美东时间：8:00AM
美西时间：5:00AM
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Meeting ID:?925 3764 5653
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视频号“上海滩老纪”，同步直播，但是想提问，请加入zoom会议。
中美医疗诊断协会CAMDA
特邀Top专家分享“EUA和510k的成功诀窍”
库尔集团A班长李雨峰邀请亲手成功过n个新冠抗原EUA的CRO专家，为中国企业来做一期讲座。深度分享“EUA和510k”的成功诀窍！
1. 演讲专家, Jinjie Hu
主题：揭秘EUA 面纱，选择正确方向前行
胡劲捷，比较病理博士，加州大学戴维斯，美国NIH/NIAID博士后。12年FDA工作经验，10年资深顾问，精通FDA法规和WHO PQ 要求? ??
Jinjie has very successful track records in supporting companies submitting companion diagnostic products, combination products, and applications for IND, 510(K), de novo, PMA, Clinical Laboratory Improvement Amendments (CLIA) waivers, IDE, IND, EUA and device Master File. As a trained manufacturer facility reviewer and CGMP inspector at FDA, she performed many pre-approval inspections and helped company to resolve deficiency issues meeting CGMP and QSR. ?She has been serving as scientific advisor, dossier reviewer and manufacturer facility inspector for the In Vitro Diagnostic Pre-Qualification Program at WHO since 2009. She provided leadership to collaborate with developing and emerging regulatory agencies for regulatory capacity building and training for many international regulatory agencies while serving as the co-chair for the International Network Committee of the FDA Alumni Association.
Jinjie received her B.S. in Cell Biology from Beijing Normal University and her Ph.D. in Comparative Pathology from UC Davis, and completed her post-doctoral training at NIAID, NIH
2. 演讲专家，Chermaen Wong
Chermaen Lindberg,?President and CEO of CovarsaDx,brings more than 25 years of experience in 这类专业极少有高数或者英语，也属于社会需求度比较高的专业类型，是自考专业当中相对来说更适合自学的类型。在线咨询新生报名！广东自考本科法学专业分为法律和法律（独立本）两个方向，主考院校为暨南大学和广东财经大学，两个专业不同，对于考生的要求也不同：二、小自考专业动漫设计、视觉传播设计与制作、环境艺术设计三个，都是广州小自考专业，是自考专科当中最简单的一类专业。考试课程以实践考核为主，笔试为辅，实践考核的最大特点就是简单，校考为主，对于考生基础要求较低，是非常适合想要尽快考完毕业的考生来考的。 research and the healthcare industry to CovarsaDx?.?Her comprehensive clinical study oversight includes protocol and study design, data management and programming, site selection and management, and clinical study reporting. During the COVID-19 pandemic,Chermaen led her clinical research team in the execution of over 20 COVID-related studies?and played key leadership roles in NIH funded projects under the RADx Venturewell program.?
To date, her clinical research group?successfully completed?10?clinical studies which attained?Emergency Use Authorizations for COVID-19.?Chermaen’s expertise continues to ensure that the clinical research team efficiently execute every project under her supervision.
3.?演讲专家，李华民?医生
11/如今各类职称评定几乎都与学历挂钩。在评定高级职称时专科及以下基本没有机会，而许多的单位主管领导几乎是由高级职称的人担任的，没有高级职称会丧失很多晋升机会。没有学历，晋升会非常困难。外企一直都是高薪，高大上的代名词，很多人想要入驻外企但是不符合要求。而想要进入外企，第一个要求就是学历要求，外企同样没有全日制和非全日制的硬性要求，所以有想要进入外企的同学不要停止学历提升的脚步。自考学历是国家承认的学历，自考本科文凭与统招生的毕业文凭同等对待。2016 - President, Institute for Asthma and Allergy, P.C.?
3/2020 - President, MedBio Reference Laboratories, Inc.?
4/2020 - President/CEO, Virant Diagnostic, Inc.?
4/2018 - Director, IAA Clinical Laboratory 6/2022 - Director, IAA Clinical Research, Inc.?
11/2019 - Medical Director, Montgomery Infusion Center
临床实验室方面的经验
4/2019 - Laboratory director, high complexity CLIA certified clinical laboratories. RT-PCR, ELISA, different immunoassays, flow cytometry, NGS, mass spectrometry, rare disease diagnosis using molecular technologies.?
1/2017- Supervising IAA Clinical Lab operation; GLP, 目前自考开设的专业整体来说，管理类专业是相对比较简单的，如人力资源管理、行政管理、商务管理、金融管理、工商管理、现代企业管理等等！有的管理类自考本科一年可以考完必考科目，如人力、商务管理等！严格来说，自考主考院校都是一样的，然而在实际报名时，有的考生会问这个问题，学校名气我们一般以统招全日制学校名气为主，目前本土深圳大学，华南师范大学都是不错的选择。 GCP, and laboratory procedure, protocol, validation, development, and implementation; Reviewing Quality Monitors with the Technical Director; Clinical Interpretation of lab results and reports
5/2008- Collaborate/consult with clinical/academic laboratories in developing, validating, implementing diagnostic assays, ELISA, Flow cytometry, PCR and rt-PCR, Sanger and NGS, etc.
08/2002- Physician in charge of CLIA-waived testing, such as Strep A, Influenza, Urine pregnancy, KOH, etc.
4. 演讲专家，Dennis
With over thirty-five years of experience with in 自学考试设置的考试科目一般情况下是有12-16门左右，而想要拿到自考毕业证是需要把这些科目全部通过之后才能够申请的。因此自学考试多久拿毕业证书需要考生自己来决定。说实话，对于学历较低的朋友来说，通过自考拿本科学历，意味着能有更高的收入，找到更体面的工作，获得的社会资源更多，未来的路会更广阔，所以自考本科的优势是显而易见的。哪怕自考本科学历是非全日制的，但在成人教育学历里，自考本科也是社会认可度比较高的学历，因自考本科考试比较难，且要考11-18门科目，需一门一门考完才能申请毕业，因此很多自考生在报名后，都会报个自考助学班，跟着老师备考，接受系统性的学习，才能提高自考通过率。 vitro diagnostics and in clinical research. Dennis Broyles, Vice President of CovarsaDx, has a proven track record of successful clinical trial completion with regulatory approvals in the US (PMA, de novo 510(k), 510(k)) and OUS. His diverse skill set includes several aspects of clinical operations from strategic planning to protocol development to data management and interpretation, in multiple diagnostic/therapeutic areas including urology, infectious diseases, women’s reproductive health, and digestive and kidney diseases.
5. 演讲嘉宾，A班长李雨峰
库尔科技集团董事长，CorDx 11月拿下了新冠抗原的EUA。
自学考试时间