Investigational Medicinal Product (IMP) Manufacturing & Management

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Investigational Medicinal Product (IMP) Manufacturing & Management

Book a session

Date	Product	Location	Price
No sessions planned as this time, however if you are interested in taking this course please contact us at info@eccrt.com

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
This course has been granted PharmaTrain Recognition

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)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

Trainers

Ms. Jolanda Muurman

Trainer