This course provides a full introduction to pre-clinical safety testing relating to regulations and guidelines in Europe at the national, Committee on Human Medicinal Products (CHMP), and International Conference on Harmonisation (ICH) levels. The course may feature tailored case studies, including in-depth discussions of specific contemporary scientific/regulatory preclinical issues, and/or instructor-led group work on specific cases.
Instructors are leading European-based experts in preclinical safety testing and safety sciences. Topics are presented through interactive lectures and hands-on workshop training methods, with emphasis on practical application of the regulations and guidelines pertinent to pre-clinical and clinical medicines development and registration. The course focuses on development of small molecule medicines and biologically derived medicines.