An Investigational Medicinal Product (IMP) is a pharmaceutical formulation of an active substance that has progressed to the clinical trial stage of drug discovery. Following preliminary studies, taking into account drug delivery systems and suitability based on the physicochemical properties of the compound, a formulation is presented for use in clinical trials. IMPs are only to be used in clinical trial settings. This course introduces you to the need, supply, handling, and disposal of IMPs including the authorization process. This knowledge is necessary for sponsors, researchers, and those involved in the management of clinical research.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Introduction
Lesson 1: Information on IMPs
Lesson 2: Supplying and Handling of IMPs
Lesson 3: Quantities of the IMPs Required for Clinical Trials
Lesson 4: Clinical Trials
Lesson 5: Quality Control
Lesson 6: Safe Disposal of Unused IMPs
Glossary
Definitions
Conclusion
Quiz
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