Sign Up in Advance【International Live Webinar Series】Clinical Trial Management Series 國際臨床試驗管理系列課程 (預約報名)
Organizer (主辦單位)：ARC-TRAICOA
Co-Organizer (協辦單位)：Salt and Light Institute 台灣光鹽生技學苑

Location (課程地點): Online Webinar Training
Date (課程日期): Early 2021 (GMT+8)

Instructor (授課師資)：
Anika Staack, Founder of ARC-TRAICOA / EU-QPPV

【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)

【Course Outline】
Part I: Management for Study Drug Supply in Multinational Trials (多國多中心臨床藥物供應管理)
Part II: Conducting Clinical Trials and Writing Relevant SOPs (臨床試驗的執行及計畫書撰寫)
Part III: Clinical Trial Risk Management (臨床試驗之風險管理)
Part IV: Audits and Inspections of Clinical Trials in Europe (歐洲臨床試驗之稽核及查核)


【Online Course Fees】
★Price per course: $200 USD (單堂課程$200美元)

★Price for Clinical Trial Series Bundle:
Clinical Trial Series Bundle (Part I - Part IV) — $700 USD,(original price $800 USD) (全選4堂臨床系列課程 優惠價 $700美元, 原價 4堂 $800 美元)

(*1) Certificate of Attendance will be issued only if participants attend the entire series of webinars (上課時數滿12小時，核發本課程結業證書)
(*2) Certificate of Completed Assessment will be issued only if participant pass the assessment (通過課程測驗者，核發課程測驗通過證書)

【Instructor CV】
Anika Staack

Current Position (現職):
Founder of ARC-TRAICOA
EU-Qualified Person for Pharmacovigilance (EU-QPPV)
Local German QPPV Consultant and Speaker

Previous Experience (經歷):
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 (專業背景):
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 (學歷)
Master of Science (Biology)

Contact Information (聯絡方式):
ARC-TRAICOA：anika.staack@gmail.com
Salt and Light Institute：bioschool@biotech-edu.com / (+886)-0928-306-821

✨Grab your seats before it's too late! Spaces are only limited to 20 people (請從速報名，名額只限20位!)✨
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Please write the name same as in your Passport for the purpose of issuing Certificate and Invoice. 請填寫護照英文名以便製作證書及收據。
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**Please use this Email for the rest of the registration processes. You should receive Payment Confirmation, Webinar Notification, and other Important Emails with regard to your rights. Please mind your spam folder if you are using Hotmail or Yahoo. (**確認匯款信、上課提醒通知信及重要權益通知等，一律以此信箱為主。若為Hotmail或Yahoo信箱請留意垃圾郵件)
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完成填寫此課程報名表單，即表示您同意ARC-TRAICOA及光鹽生物科技有限公司出於未來通知課程目的收集和使用您的個人信息。通知將透過電子郵件、電話等方式，提供您相關資訊。收集的信息將依台灣《個人資料保護法》和歐洲《通用數據保護條例》（GDPR）的規範，包括用於保護個人數據的機密性和處理的安全性。我們將盡最大的謹慎對待您的個人信息，絕不會將其提供於其他公司。
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