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Investigational Medicinal Product Order for Clinical Studies

 5/5

40

Investigational Medicinal Product Order for Clinical Studies

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

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:

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

Reviews:

 5/5

40

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!

$60

Buy now

This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.