Grab your seats before it’s too late！Spaces are only limited to 16 people. Next session will only be held if all the 16 spaces are filled！
Organizer：ARC-TRAICOA
Co-Organizer：Salt and Light Institute
Location：Online Webinar Training
Date：
Part1：2020/12/01(Tues) 16:30~18:00 (GMT+8)
Part2：2020/12/03(Thurs) 16:30~18:00 (GMT+8)
Instructor：Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
【Target Audience】
- Anyone who is interested in clinical trials in Europe
- 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 1：2020/12/01(Tues) 16:30~18:00 (GMT+8)
A. Europe – One Union with differences
B. European Clinical Trial Directive
- Role of national competent authorities
- Role of ethics committees (central / local)
- Role of investigator
- Role of sponsor
- Role of EMA
C. Planning clinical trials in Europe
- Analysis of product
a.Indication
b.Patient group - Analysis of end points
- Analysis of protocol
- Preparing feasibility
- Choosing Key Opinion Leaders
- Sponsor or IIT?
- Similar studies already running?
Part 2： 2020/12/03(Thurs) 16:30~18:00 (GMT+8)
A. Applying clinical trial
- Collecting information you need
- 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
- Doing it by yourselves
- Contracting CRO
- 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
【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)
