【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
