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Overview
Key module objectives
• Define bioproduct and biopharmaceutical
• Compare biopharmaceutical and chemical pharmaceutical
• Identify development steps of a biopharmaceutical
• Identify manufacturing steps of a biopharmaceutical
• Identify global regulatory
framework leading to commercialization
Target audience
Employee from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector
Module Overview
Activity 1: Bioproducts and biopharmaceuticals
• Definition of bioproducts or biobased products and identification of different sources;
• Presentation of the main differences between bioproduct and biomanufacturing
• Introduction to the 5 main families of bioproducts
• Regulatory
definition of a biopharmaceutical, examples of biopharmaceutical origins
• Presentation of the 3 main types of biopharmaceuticals: Vaccines, Proteins, ATMP
• Short introduction to the regulatory framework of biopharmaceuticals
Activity 2: Development phases, manufacturing steps, and regulatory framework of biopharmaceuticals
• Presentation of the development phase of a biopharmaceutical product (Research, Pre-clinical studies, Clinical production, Clinical trials, Marketing authorization, Price & reimbursement rate)
• Detailed presentation of the 3 main
production steps (and their different sub-steps) and illustration via examples: USP, DSP, F&F
• Global presentation of the global regulatory framework leading to commercialization
Activity 3: Jobs in the biopharmaceutical Industry
Learner will play a recruiter who will:
• Place each CV in the right job family
• Practice to position each job in the life cycle of a biopharmaceutical project and chemical pharmaceuticals
• Make interactions between the main job
families (product, control, regulatory & marketing jobs)
• Module evaluation quiz
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Gamified eLearning / Serious Game 3D
Evaluation procedures
• A final evaluation at the last module to assess what you have learnt in the curriculum (max. 3 attempts, 80% of correct answers required)
Required equipment
Recommended equipment for an optimal experience : PC computer, with the last version of web browsers Chrome/Firefox/Microsoft Edge, and an internet connection of 8 Mb/s or more.
Face to face training
Not Applicable
Contact for any question
Module Version Level & Date
Module 1 - Version Master Essential from 18/11/2022
Accessibility
The courses of this Module meet WCAG standards with the exception of contents in 3D. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
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