This training course is designed to give pharmaceutical and biologic companies operating in the US an introduction to the fundamentals of product safety and regulatory compliance. It will also give you a jump-start on how to prevent common problems that are found during regulatory inspections for drug safety and pharmacovigilance. It will include examples based on the top ten findings by FDA pharmacovigilance inspectors. You will be able to use this information straight away to make the changes you need to address these common failings and avoid the findings.
You can be sure regulatory authorities will inspect your drug safety operations - and there is no excuse for poor preparation.
This training course is designed to give pharmaceutical firms operating in the US practical information, best practices and insight to help ensure compliance with the most recent drug safety and pharmacovigilance regulations.
Whether you're planning an internal audit of your processes, anticipating an audit from a business partner, or preparing for your FDA inspection, this course will give both old hands and new staff the insights needed to be ready for regulatory scrutiny of your drug safety and pharmacovigilance specialists, safety processes, safety systems and reporting.
- An understanding of FDA regulatory requirements for drug safety
- Knowledge of how to collect, assess, report and analyze adverse events to meet FDA requirements
- Overview of US regulatory framework
- The top ten findings from FDA pharmacovigilance inspections
- The objectives and components of a pharmacovigilance audit
- Practical steps to help you begin and implement your audit
- Examples of what NOT to do
Who Will Benefit
- Clinical safety staff
- Pharmacovigilance specialists
- Regulatory affairs professionals
- Quality management specialists
Management involved in clinical oversight