【International Live Webinar Series】Strategies for Applying Clinical Trials in Europe歐洲臨床試驗申請策略與佈局
🌍此次學苑特別推出國際線上同步遠距課程,並與德國講師合作,提供學員最新的國際臨床試驗實務課程!
此次課程為系列課程,首堂為”歐洲臨床試驗申請策略與佈局”。對於想往歐洲發展、合作或與歐洲從事臨床試驗的相關公司廠商有很大的幫助!
Date:
Part 1: 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
Part 2: 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
Location:Online Webinar Training
Instructor:Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
【Course Outline】
Part 1 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
A. Europe – One Union with differences
B. European Clinical Trial Directive
1.Role of national competent authorities
2.Role of ethics committees (central / local)
3.Role of investigator
4.Role of sponsor
5.Role of EMA
C. Planning clinical trials in Europe
1.Analysis of product
a.Indication
b.Patient group
2.Analysis of end points
3 .Analysis of protocol
4.Preparing feasibility
5.Choosing Key Opinion Leaders
6.Sponsor or IIT?
7.Similar studies already running?
Part 2 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
A. Applying clinical trial
1.Collecting information you need
2.Establishing study team
B. Required entry into EudraCT
C. Required approval from national HAs and ethics
D. Required fulfilment of national data protection laws
E. Considerations
1.Doing it by yourselves
2.Contracting CRO
3.Auditing
F. Upcoming issues: Site and patient recruitment, site resources, patients withdrawal, protocol amendments
G. Final presentation of study reports
Online Course Fees include 2 Webinars, 90 minutes each:
Special Price $160 USD per Person; Original Price $180 USD
(*1) Certificate of Attendance will be issued only if participants attend both part 1 & 2 webinar
(*2) Certificate of Completed Assessment will be issued only if participant pass the assessment
Register here 👉 https://forms.gle/Kj9yMVynsq7yzSzs8
Organizer:ARC-TRAICOA
Co-Organizer:Salt and Light Institute
【Target Audience】
(1.) Anyone who is interested in clinical trials in Europe
(2.) Anyone who has experience in working in clinical trials related field such as PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA, etc)
【Instructor CV】
Anika Staack
Current Position:
Founder of ARC-TRAICOA
EU-Qualified Person for Pharmacovigilance (EU-QPPV)
Local German QPPV Consultant and Speaker
Previous Experience:
EU-QPPV / Stufenplanbeauftragte & Group Leader PV at Medice
Senior Drug Safety Manager at ICON
Lead Site Management Associate at PRA
Clinical Research Associate at SKM Oncology
Expertise:
Expertise Databases: European Medicine Agency EudraVigilance and xEVMPD
Quality Assurance: Audits & Inspections, SOP Writing and QA documentation, recalls and product quality
Clinical Trial Management: Feasibility, monitoring, eCRF set-up, database reconciliation, site selection, contract management, patient recruitment, study reports
Authorization process: PSMF, RMP & PSUR Writing, answering authority requests, Risk Management, overseeing product life-cycle
Education Background:
Master of Science (Biology)
Email: bioschool@biotech-edu.com Tel: (+886) 02-2545-9721 ext.18
cra申請 在 台灣光鹽生物科技學苑 Facebook 的最佳解答
✨✨光鹽開辦國際合作線上同步遠距研討會 (Live Webinar) - Anika Staack 講師介紹✨✨
🎉台灣光鹽生技學苑國際合作組伍亮霓召集人引薦了多位歐洲的產業專家擔任講師,首先學苑很榮幸地在此宣布 我們與德國醫藥顧問公司ARC-Traicoa UG (haftungsbeschränkt) 正式合作辦理國際線上同步遠距研討會(Live Webinar) 💻
我們的主講者,Anika Staack老師👩,在EMA及歐洲各國從事臨床試驗領域已有16年餘載的經驗,且身為EU-QPPV的一員,更是醫藥品申請NDA前及上市後不可或缺的角色。希望學員有機會一同參與線上課程,感受國際交流第一手資訊的悸動!💕
Anika也很親切、熱心地提供了她的一段自我介紹及影片,希望各位能在線上同步遠距研討會(Live Webinar)中與她互動:
“Greetings! My name is Anika Staack. I have more than 16 years of experience in the field of clinical trials and post-marketing of medicinal products. In the past, I had worked as CRA, Trial Site Manager, and Drug Safety Manager for global clinical trials of various indications and patient age groups. For several years now, I have been working as an EU-Qualified Person for Pharmacovigilance (EU-QPPV), overseeing product lifecycle of medicinal products, supplementals, and medical devices. Additionally, I have expertise in a wide array of clinical trial activities, ranging from audit and inspections, Quality Assurance, Regulatory Affairs, Manufacturing, to Marketing. I am knowledgeable about several databases and European pharmaceutical laws and regulations. Moreover, I have been providing training for FORUM Institute about Audits and Inspections and Risk Management. I am thrilled to meet you all in my webinar sessions. See you then!” ✨✨
cra申請 在 台灣光鹽生物科技學苑 Facebook 的精選貼文
~開放報名中~ 2020/9/19 (星期六)【新藥開發系列】- 癌症免疫細胞治療法規與研發實務
授課師資:台灣幹細胞學會 張文瑋秘書長
長聖國際生技股份有限公司 張立勳經理
台灣細胞醫療協會 林泰元秘書長
【授課大綱】
癌症免疫細胞治療之原理與機制
1.再生醫療法草案vs特管法之比較
2.免疫細胞治療的原理與機制
3.免疫樹突細胞之體外培養
4.免疫樹突細胞之保存
人體細胞組織優良操作規範與認證
1. GTP (人體細胞組織優良操作規範)
2. GTP實驗室認證
細胞治療醫療院所執行現況與未來發展
1.台灣細胞治療醫療院所執行現況
2.國外細胞治療執行現況與未來發展
學員對象:
(1)對細胞治療、再生醫療工作有興趣者
(2)參加過本學苑新藥或臨床試驗及系列課程者
(3)目前從事臨床試驗相關工作者 (如PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA等…)
(4)藥事人員 (繼續教育學分已完成申請,共7.3點)
主辦單位:台灣光鹽生物科技學苑, 台北市西藥商業同業公會
課程地點:光鹽會議中心
課程日期:109年9月19日 (六) 09:00至17:00 (08:30 開始報到)
*本課程藥事人員繼續教育學分已完成申請
(專業課程5.5點、專業相關法規1.8點,共7.3點)
認證字號: [臨藥繼字 第1090728號]
報名方式:https://forms.gle/oLCiHoK419GhZPZx9
課程費用:每人2,500元; 在學學生本學苑補助20%,每人2000元 (在學生報到時,出示學生證或相關在學證明文件即可) p.s. 含中午供餐及中場休息點心
*上課達滿時數六小時,並完成案例演練者,核發本課程結業證書
*因應疫情變化,為維護上課學員之健康,實施下列安心防疫培訓政策:
1.自本學苑公告日起(2020/3/11)至開課日(2020/9/19),全面限制自境外返台者(不分國家)參加本學苑課程。
2.自課程公告日起(2020/8/20)至開課日(2020/9/19)凡有收到居家隔離、居家檢疫、自主健康管理者,均不得參加本學苑課程。
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