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.
Webinar Takeaway
- 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
3.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 3.0 credits towards a participant's RAC recertification upon full completion.
Speakers
Mr Steve Jolley,
DIASteve Jolley is a subject matter expert in all areas of global safety compliance and signal detection.
Steve has 37 years’ experience in drug safety & pharmacovigilance and has worked with 300 clients in North America, Europe, Japan, India, China, the Middle East, and Africa. He holds degrees in mathematics and computer science from Cambridge University, England. He is an Adjunct Professor at Rutgers University and developed part of their Master's degree in Drug Safety and Pharmacovigilance.
Steve is a featured speaker with FDA, EMA and MHRA at conferences and webinars on auditing, signalling and data mining. He is a member of DIA’s training faculty and is an instructor for DIA’s Clinical Safety and Pharmacovigilance Certificate Program. In 2010 Steve was elected as chairman of the DIA’s Clinical Safety and Pharmacovigilance steering committee for North America.
Who Should Attend
- Clinical safety staff
- Pharmacovigilance specialists
- Regulatory affairs professionals
- Quality management specialists
- Management involved in clinical oversight
