Enrolment for IMP Supply course opens from 9th Jan 2024
Name of the course: Investigational Medicinal Product Supply
Edition of the course: 1st Edition
Starting date: 9th January 2024
Closing date: 30th April 2025
Enrolment Dates: Enrol anytime from 9th Jan 2024
Course Duration: 1 hour
To enrol in this course, please contact your National Hubwho will supply you with the course password.
Your National Hub’s Referent Person for Training and Education will verify your eligibility to enroll to the Course and provide you with the Course’s enrolment password.
Once you receive this Course’s Enrolment Password from your National Hub, please log in on c4c Academy Platform.
If you don’t have an account yet, click on Create new account and follow the instructions.
General Description:
This self-learning course introduces key aspects of investigational medicinal product supply planning, including regulatory requirements, blinding, placebo supply, and forecasting. All regulatory considerations are kept at an introductory level, such that the materials are suitable for all those involved in clinical trials without detailed understanding of pharmaceutical manufacturing.
Programme:
Lesson 1:
Explain and give examples of the differences between a drug and a medicinal product
Define an investigational medicinal product (IMP)
Outline the different IMP regulatory requirements
Describe the factors to consider when planning IMP supply for a clinical trial
Lesson 2:
Understand the practical aspects of blinding in the context of randomised controlled trials of drug treatments
Define a placebo
Understand the various factors to consider when manufacturing placebos
Lesson 3
Understand the various factors to consider when forecasting IMP supply
Understand how effective IMP planning and production scheduling can minimise trial start-up delays, and avoid treatment interruptions for trial participants.
Who should apply?
This course is suitable for anyone interested in learning about investigational medicinal product supply. Target audience include but not limited to investigators, trial coordinators, clinical trial pharmacists, and all those involved in the design and planning of clinical trials
Max. number of persons that each national hub can enrol: unlimited
