GXP2276 Investigational Medicinal Product Order for Clinical Studies

GXP2276 Investigational Medicinal Product Order for Clinical Studies

Description:

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.

 

 

 

Curriculum

 

Introduction

 

Lesson 1: Information on IMPs

 

Lesson 2: Supplying and Handling of IMPs

 

  • Storage
  • Accountability
  • Documentation

 

Lesson 3: Quantities of the IMPs Required for Clinical Trials

 

  • Manufacturing Process Development
  • Composition of the IMP

 

Lesson 4: Clinical Trials

 

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

 

Lesson 5: Quality Control

 

  • Stability Study
  • Raw Material Management
  • Complaints

 

Lesson 6: Safe Disposal of Unused IMPs

 

Glossary

 

Definitions

 

Conclusion

 

Quiz

Author:

GXP2276 Investigational Medicinal Product Order for Clinical Studies
Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects

General info:

Duration:

1 hour

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

IMPs provide a semblance of what the end product of the drug discovery timeline should look like. It was only necessary for our employees to learn about these. Dokeos did the job just fine!

Michelle V

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Director of Operations

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GXP2276 Investigational Medicinal Product Order for Clinical Studies

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