【International Live Webinar Series】
Clinical Trial Management Series
國際臨床試驗管理系列課程
Organizer：ARC-TRAICOA Co-Organizer：Salt and Light Institute
Location：Online Webinar Instructor：Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
【Course Outline】— Clinical Trial Series
★ Each online webinar (3 hrs) has 2 sessions, 1.5 hrs each ★
Webinar # | Topic | Date |
Part I | Management 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 II | Conducting 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 III | Clinical Trial Risk Management | Session 1: 3/9 20:30~22:00 Session 2: 3/11 20:30~22:00 (Sign-in Time: 20:00~20:30) |
Part IV | Audits 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) |
【Target Audience】
(1.) Anyone who is interested in global clinical trials
(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)
【Online Course Fees】
★Price per course: $200 USD
★Price for Clinical Trial Series Bundle:
Clinical Trial Series Bundle (Part I - Part IV) — $700 USD, (original price $800 USD)
Registration Link:
https://forms.gle/E24XvW8Y34ReTP1w9
(*1) Certificate of Attendance will be issued only if participants complete both sessions of each webinar for which they have signed up
(*2) Certificate of Completed Assessment will be issued only if participants 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