Investigational Medicinal Product (IMP) Manufacturing & Management (location Brussels!)

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)?

Duration
1 day
Course fee
€ 795 (excl. VAT)

Short 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.

Objectives

  • Gaining understanding and knowledge of GMP
  • Understanding the importance of process flows and structures within the GMP system
  • Understanding GMP related to the manufacturing and testing and how this relates to the activities performed in the clinic with that material

Target group

This 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 all staff who want to know more about GMP or who work in a pharmaceutical company but have not (yet) worked under GMP conditions.

Program

 

• 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

Sign up

  • Keep me up to date

    Leave your e-mail address to receive a notification when new training dates become available.
    Your e-mail address will not be used for other purposes.

Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Knowhow.
Know how.
Know why.

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

Thanks