You are currently viewing <已截止>【International Live Webinar Series】Clinical Trial Management Series 國際臨床試驗管理系列課程

<已截止>【International Live Webinar Series】Clinical Trial Management Series 國際臨床試驗管理系列課程

Co-Organizer:Salt and Light Institute
Location:Online Webinar Training
Instructor: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】——Clinical Trial Series

Each online webinar (3 hrs) has 2 sessions, 1.5 hrs each

Webinar #TopicDate
Part IManagement for Study Drug
Supply in Multinational Trials
Session 1: 2/23 20:30~22:00
Session 2: 2/25 20:30~22:00
(Sign-in Time: 20:00~20:30)
Part IIConducting Clinical Trials and
Writing Relevant SOPs
Session 1: 3/2 20:30~22:00
Session 2: 3/4 20:30~22:00
(Sign-in Time: 20:00~20:30)
Part IIIClinical Trial Risk ManagementSession 1: 3/9 20:30~22:00
Session 2: 3/11 20:30~22:00
(Sign-in Time: 20:00~20:30)
Part IVAudits and Inspections of
Clinical Trials in Europe
Session 1: 3/16 20:30~22:00
Session 2: 3/18 20:30~22:00
(Sign-in Time: 20:00~20:30)

Online Course Fees

Price per course:$200 USD
Price for Cinical Trial Series Bundle:
Clinical Trial Series Bundle (Part I~Part IV)——$700 USD (original price $800 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 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)