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.