【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
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📍Accounting Assistant📍
Responsibilities:
- Prepare invoice, contract, receipts, payments, accrual and journal vouchers.
- Check staff expenses claims.
- Prepare bank reconciliation statements.
- Perform daily accounting work
- Input data into accounting software
- Assist in month end closing and preparation of accounting schedules.
- Handle other ad hoc assignments
(Immediate available is preferable)
Requirements:
- Form 5 or above
- 1 - 2 years working experience preferable in Accounting work
- Proficient in MS Word, Excel and Accounting Software
- Good command of spoken and written English and Chinese, including Mandarin
Fresh graduates will also be considered
Salary
HK$12K – HK$15K (Negotiable)
Benefits
- Year-end discretionary bonus
- Provide professional on-the-job training
- Bank holiday
- Paid annual leave
- Birthday Leave & Compensation Leave
- 5 days work
- Overtime pay
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【新藥開發系列】-臨床試驗監測實務培訓班
#臨床試驗開始前的準備項目 #臨床試驗開始 #臨床試驗實地監測 #臨床試驗結案
主辦單位:台灣光鹽生物科技學苑
訓練地點:光鹽會議中心 (台北市復興北路369號7樓)
課程日期:107年06月08日(星期五) 09:00-17:00
授課師資:江君敏 資深臨床研究專員
學員對象:
(1)對臨床試驗相關工作者有興趣者
(如PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA,MW等…)
(2)曾參與本學苑或其他新藥/臨床試驗課程的學員
(3)生技公司/新藥公司/藥廠或CRO現職人員
【授課內容】
一、臨床試驗專員在試驗受託機構的角色 CRA role in CRO
-試驗受託機構的組織介紹CRO dept.
-部門分工與職責介紹 job description
二、臨床試驗開始前的準備項目Pre-study Activities
-可行性評估feasibility
-試驗開始前醫院實地訪視 pre-study site visit
-臨床試驗啟動study start-up
三、臨床試驗開始Site initiation
-臨床試驗首次訪視的準備SIV(Site initiation) preparation
-臨床試驗首次訪視後的工作項目post-visit activities
-案例演練Practice
四、臨床試驗實地監測Site monitoring
-監測計畫Monitoring plan
-原始資料驗證Source Data Verification
-臨床試驗監測報告Monitoring report
-試驗主持人檔案/試驗檔案一致性確認Investigator site
file/ Trial master file reconciliation
-案例演練Practice
五、臨床試驗結案Site Close-out
-試驗結案訪視之準備COV(Close-out) preparation
-試驗結案訪視後之工作項目post-visit activities
*上課達滿時數六小時,將核發本課程結業證書。
課程費用:每人2,500元 (中午供餐及中場休息點心)
報名方式:<線上報名> https://goo.gl/forms/0bz1vygmpC1As7dm1
***因名額有限,請務必確認當日可來上課再報名,以避免候補者等候***
【師資介紹】
江君敏
學歷:
中山醫學大學護理系畢業
經歷:
美捷國際有限公司 資深臨床研究專員
科文斯諮詢服務股份有限公司 資深臨床研究專員
台灣中外製藥股份有限公司 臨床研究專員
佳生科技顧問股份有限公司 臨床營運經理
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