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Dorint An der Messe Basel

Nov 02, 2015 8:00 AM - Nov 04, 2015 5:00 PM

Schönaustrasse 10, 4058 Basel, Switzerland

Clinical Trial Management Essentials

Overview

All you’ve ever wanted to know about Clinical Study Management... and more
Learn the Ins-and-Outs of Study Management, the Clinical Study Environment, and overall Drug Development

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The success of a clinical trial depends on efficient preparation, effective conduct and oversight.
This training course provides a comprehensive overview of the essential elements of clinical trial  management and overall drug development process, using real case studies, practical examples and group exercises.
After successful completion of the training course, participants will be able to plan, execute and manage a clinical study.

What participants from previous course say:
"Every session was very interesting with lots of interaction with the participants"
"Very good instructors, keep on going that way"
"The course was very informative and good organized"

What you will learn

  • Drug Development Process
  • Feasibility Assessments
  • Study Planning Tools
  • Regulatory Framework
  • Quality Management System
  • Vendor Selection
  • Resource Management
  • Investigational Product Handling
  • Site Management
  • Risk Identification and Mitigation
  • Safety Reporting
  • Study Evaluation and Reporting

Who should attend?

This course will particularly benefit those newly appointed to a clinical study management position, e.g. monitors and clinical research professionals with some basic experience in the field of clinical research, who need a broader understanding of the principles of clinical study management. This course will also benefit those who interact with clinical trial managers (such as IT, Finance, PV, QA and CTAs) as well as those in an academic research setting who interface with industry.

Learning objectives

This course will provide the strategies and tools to prepare, launch and manage a clinical trial from protocol to final report.
At the conclusion of this course participants will be able to:

  • Describe the clinical research phases and basic concepts of study design
  • Explain the regulatory framework in which studies are conducted
  • Identify the activities involved in study planning and start-up, including feasibility and budgeting
  • Qualify, select and oversee vendors and external resources for the study
  • Define performance metrics
  • Identify various types of clinical trial communication plans
  • Describe the data management and statistical evaluation process
  • Manage the final study report preparation
  • Recognise European safety reporting requirements
  • Understand what a quality management system is and how to achieve compliance with ICH-GCP and applicable regulations
  • Discuss risk management (including risk based monitoring) and contingency planning

Digital Learning Catalog

DIA Learning: eLearning Soultions
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Ways to register

Registration fee includes refreshment breaks, lunch on the 1st day of the course and training course material.

For bank transfer payment please use the printable registration form which is available at the back of the programme (click on View PDF below).

This course has limited capacity. Register early!

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