Organizer：ARC-TRAICOA
Co-Organizer：Salt and Light Institute
Location：Online Webinar Training
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】——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) |
【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:
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)
