Training course on Non-Clinical Safety Sciences and Their Regulatory Aspects

Featuring tailor-made case studies including in-depth discussion of specific contemporary scientific/regulatory preclinical issues, case-studies and/or instructor-led group work on specific cases.

This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.