Non-Clinical Safety Sciences and Their Regulatory Aspects

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.

• Role of pre-clinical safety studies in medicines development and registration in Europe
• Pre-clinical medicines discovery and development from regulatory and industry perspectives
• Translational aspects of pre-clinical safety sciences, including safety biomarkers
• Pre-clinical safety studies and timing to clinical development and registration
• Contemporary scientific and regulatory topics, such as environmental risk assessment, safety pharmacology, pharmaco-toxicokinetics, and metabolism
• Aspects of vaccines, anti-cancer medicines, and biotechnology-derived medicines

• Professionals in pre-clinical research and development, project management, regulatory affairs, and medical writing
• Clinicians for Phase 1 and pharmacovigilance
• Professionals in regulatory agencies outside Europe
• Professionals who have a fair understanding of aspects of medicines development and registration

http://www.on-course.eu/search_courses.htm?execution=e1s16

Participants who complete this course should be able to:

• Discuss the scope and needs for pre-clinical safety programmes in relation to clinical trials in Europe
• Discuss calculations of first-in-human doses
• Identify requirements for successful pre-clinical medicines development in Europe
• Describe European culture and complexity in the registration system
• Explain the fundamentals of pre-clinical medicines development in Europe and in the ICH environment
• Share recent real-world experiences of pre-clinical medicines development agencies and companies in Europe