• The origins and evolution of drug safety, including consensus groups, key legislation, global standards, and how to speak the language of pharmacovigilance
• US and European postmarketing pharmacovigilance requirements, with a focus on traditional medicines and therapeutic biologicals
• Pragmatic approaches to individual case processing and aggregate data submissions
• Information technology, data protection needs, and ethical issues associated with drug safety
• The basics of drug safety inspections, including case studies
• The anticipated future direction of travel for postmarketing pharmacovigilance requirements

Professionals who work in:

• Global drug safety, pharmacovigilance, and risk management
• Regulatory or legal affairs
• CROs, start-ups, small companies, or generic drug companies
• SOP development or quality systems
• Areas responsible for training and teaching of drug safety and pharmacovigilance 
• Clinical health care
• Out-licensing or in-licensing of biopharmaceutical products
• Outsourcing or off-shoring of drug safety activities
• Supervisory capacities in drug safety or functions related to pharmacovigilance
• Patient advocates

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

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

• Identify the legal and regulatory basis of postmarketing drug safety and pharmacovigilance
• Explain the requirements, changes, pitfalls and risks in postmarketing pharmacovigilance, and apply the knowledge gained in your daily pharmacovigilance functions
• Describe your company’s drug safety system and determine whether it is meeting regulatory compliance needs and requirements
• Describe how your pharmacovigilance system will perform on an audit or governmental inspection