• Legal basis for safety obligations during interventional clinical trials, including an historical perspective
• Fundamental concepts, basic definitions, and pragmatic approaches for compliance, with a focus on traditional small molecules
• Basics of Individual Case Safety Reports (ICSRs, e.g., SUSARs) and periodic reports (DSUR, IND AR)
• Evaluation of seriousness, expectedness, and causality, including critical differences between US and EU approaches
• Importance of consistent MedDRA coding
• The safety reporting framework and inter-related roles of Sponsor, Principal Investigator, Investigational Review Board /Ethics Committee, Informed Consent, independent Data Monitoring Committee, etc.
• How to avoid common pitfalls in complying with FDA requirements for interventional clinical trials conducted under an IND
• What to expect in a preapproval safety inspection
• Premarketing risk assessment concepts and their application to drug development

Professionals involved in:

• Clinical safety and pharmacovigilance
• Clinical development, including sponsors, investigators, and study staff
• Regulatory affairs
• Quality systems
• Case processing, particularly serious ICSRs
• Clinical data management
• Medical writing
• Independent Safety Data Monitoring Board
• Outsourcing or off-shoring of drug safety activities
• Clinical health care

This training course is also designed to provide the basics for those seeking a career change into a clinical drug safety function.

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

• Discuss why premarketing clinical safety and pharmacovigilance are important
• Explain the key requirements and differences in FDA and EU regulations for premarketing clinical safety and pharmacovigilance
• Review the concepts of a preapproval clinical safety inspection
• Specify why processes, procedures, and documentation are in written form to ensure compliance with regulations and requirements
• Explain how premarketing risk assessments are performed