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Good Clinical Practice - Basic Principles

2 Days
GCP

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and European GCP requirements. The course aims to provide an overview and practical advice on the application and implementation of international accepted principles for GCP and clinical research.

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Audience

Anyone involved in Clinical Research and Management

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 1740

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea

Networking

✓ Course certificate after completion

Location

Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer
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Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.

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    Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
Program

Introduction to ICH-GCP

  • Why ICH-GCP guidelines were established

  • Legislation

  • Clinical development program

Clinical Trial Protocol

  • What does it all contain?

 

Ethics Committee

  • Which responsibilities

  • Which requirements to follow

 

Sponsor and Investigator

  • Which responsibilities

  • How to choose

Patient Recruitment

  • Informed Consent: what's in a name?

  • How to recruit?

Conduct and Monitoring

  • Data handling: is it easy or not?

  • What needs to be monitored?

  • Who will monitor?

Safety Data

  • What's the difference between an Adverse Event and an Adverse Drug Reaction?

  • How to report safety data

Essential Documents

  • What, where and when?

Closure

  • Is it time to closure?

Result Analyses and Interpretation

  • How to obtain a Clinical Study Report

Communication of Trial Results

  • How to communicate on Clinical trial results

  • What about the publication?

Data Filing and Registration

  • How to file your clinical trial data and registration

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Good Clinical Practice - Advanced Principles

3 Days

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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