【International Live Webinar Series】
Strategies for Applying Clinical Trials in Europe歐洲臨床試驗申請策略與佈局

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
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】

Part 1

A. Europe – One Union with differences

B. European Clinical Trial Directive

1. Role of national competent authorities
2. Role of ethics committees (central / local)
3. Role of investigator
4. Role of sponsor
5. Role of EMA

C. Planning clinical trials in Europe

1. Analysis of product
   a.Indication
   b.Patient group
2. Analysis of end points
3. Analysis of protocol
4. Preparing feasibility
5. Choosing Key Opinion Leaders
6. Sponsor or IIT?
7. Similar studies already running?

Part 2

A. Applying clinical trial

1. Collecting information you need
2. 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

1. Doing it by yourselves
2. Contracting CRO
3. Auditing

F. Upcoming issues: Site and patient recruitment, site resources, patients withdrawal, protocol amendments

G. Final presentation of study reports

【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)