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★Registration Closed★ Clinical Trial Management Series 國際臨床試驗管理系列課程4
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International Live Webinar Series

Clinical Trial Management Series

國際臨床試驗管理系列課程

 

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OrganizerARC-TRAICOA       Co-OrganizerSalt and Light Institute

LocationOnline Webinar         InstructorAnika 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:
<Registration is Closed>

(*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

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