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★ Register NOW ★12/1(Tues)&12/3(Thurs)【International Live Webinar Series】Strategies for Applying Clinical Trials in Europe4
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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”

 

OrganizerARC-TRAICOA

Co-OrganizerSalt and Light Institute

 

LocationOnline Webinar Training

Date:

Part 1: 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)

Part 2: 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)

 

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  2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)

  1. 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  2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)

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

 

Online Course Fees include 2 Webinars, 90 minutes each

Special Price $160 USD per Person; Original Price $180 USD

 

:
https://forms.gle/Kj9yMVynsq7yzSzs8

 

(*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)


Salt & Light Institute
Phone: +886 2 25459721 #18
Email: bioschool@biotech-edu.com

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