What you will learn
- Why preclinical safety studies are done and what preclinical data can be used for in safety assessments
- The rationale behind dose selection for first-dose-in-man trials and the reasoning behind decisions for safety margins
- The principles of safety monitoring in clinical phase I, II and III studies and regulations for the assessment and monitoring of safety issues in clinical studies
- How pharmacovigilance units can co-operate with regulatory authorities
- How to share knowledge on preclinical and clinical aspects of pharmacovigilance
What your company will get
- A safety and pharmacovigilance professional who understands why preclinical safety studies are done and what preclinical data can be used for in safety assessments
- A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of application and registration
- A safety and pharmacovigilance professional that can independently analyze and evaluate the steps in regulating drug safety
- A safety and pharmacovigilance professional who can provide valuable input to all other team members working with preclinical and clinical aspects of pharmacovigilance