• Fundamental concepts of clinical drug safety and pharmacovigilance and their application to clinical development, with a focus on traditional small molecules
• How to avoid common pitfalls in complying with FDA and European clinical safety regulations
• What to expect in a preapproval safety inspection
• Proven concepts of premarketing risk assessment and their important role in drug development
• How to effectively use signaling tools and techniques to support premarketing risk assessment

Professionals involved in:

• Clinical safety and pharmacovigilance
• Clinical development, including sponsors and investigators
• Regulatory affairs
• Quality management
• Clinical data management

At the conclusion of this activity, participants should be able to:

• Discuss why premarketing clinical safety and pharmacovigilance are important to ensure Good Pharmacovigilance Practice
• Explain the key requirements and differences in FDA and European regulations for premarketing clinical safety and pharmacovigilance
• Explain concepts of a preapproval clinical safety inspection
• Develop company policies and procedures for clinical safety
• Explain how premarketing risk assessments are performed