Investigational Medicinal Product (IMP) Manufacturing & Management
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
This course gives answers to the question of which regulatory aspects are important throughout the product development cycle. What are the GMP requirements at various stages of product development (research, animal studies, clinical phases I, II & III)?What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- One Day face-to-face training: 09h00-17h00
Course Description
This training deals with various GMP aspects that are important for the production process of (bio)pharmaceutical products.This training also discusses the different regulatory standards required during the various phases of product development (development, animal research, clinical phases I, II and III) and how IMP’s are released for the use in clinical trials.Programme highlight
- The Product life cycle
- R&D regulations
- Risk management in new product development
- Stability and shelf life studies
- Release of IMP’s for clinical trials
Learning objectives
- Gain understanding and knowledge of GMP
- Describe the importance of process flows and structures within the GMP system
- Learn GMP related to the manufacturing and testing and how this relates to the activities performed in the clinic with that material.
Who should attend
This 1-day training is developed for people who work within an R&D environment (laboratory/ production) who would like to know more about GMP, for example, to be able to adapt and adjust their development processes in accordance with future demands.
This course is also intended for clinical research professionals to get a better understanding of the manufacturing and analysis of clinical material (Investigational Medicinal Product or IMP).In fact, the training is suited for staff who just want to know more about GMP or work in a pharmaceutical company but have not (yet) worked under GMP conditions.Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (4)
- Study and Site Management (0)
- Data Management and Informatics (1)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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