From Molecule to Medicines - An Introduction to Clinical Trials including ICH-GCP
Highly interactive course with a balance of information, workshops, exercises and quizzes offering a general overview of the drug development process including relevant tasks and responsibilities within the clinical research setting.
It provides details on how drugs are developed and who the key players in the process are, about the terminology used in the clinical research environment and what rules, guidelines and laws are essential.
How a clinical study is set up and performed and how to handle the documentation required in clinical research.
• The Drug Development Process
• Good Clinical Practice / ICH Guidelines / Directives
• “Who’s Who” in Clinical Research – Roles and Responsibilities
• Conducting Clinical Trials: pre-, during and post study activities
• Clinical Trial Methodology and Design
• Understanding and Handling of Adverse Events
• Monitoring Clinical Studies