This course aims to provide delegates with an understanding of GMP requirements for IMP and practical guidelines for ensuring GMP is followed at a Phase I site
Who it is suitable for:
The course is aimed at anyone involved in the supply and management of IMP for investigational sites. For example, CTAs, CRAs, Project Managers, Pharmacists, Investigators.
Regulatory and Advisory Bodies
New EU Guideline on IMPs and Non-IMPs
Requirements for Manufacturing
What constitutes manufacturing