Preparing for a Pharmacovigilance Inspection
This training course will 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 US and EU 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 and EU 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 or EMA 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.
What You’ll Learn
- The top ten findings from US and EU pharmacovigilance inspections
- Why the pharmacovigilance audit is important to ensure Good Pharmacovigilance Practice
- The impact of global regulations on international safety reporting and review methods
- The objectives and components of a pharmacovigilance audit
- Practical steps to help you begin and implement your audit
- The requirements of all applicable regulatory bodies for your products
- Initiating company practices for drug safety across the product lifecycle
- Examples of what NOT to do
Course Content
- Audits vs. Inspections
- Types of audits & inspections
- Who can be audited?
- Overview of the pharmacovigilance audit
- Typical pharmacovigilance current process model
- Best practice approach to enhancing process model
- Achieving best practices through the pharmacovigilance assessment
- Value derived
- Audit scope
- Company sources of information to be examined
- PV checklist
- PV risk profile
- Audit report table of contents
- Prioritization of findings
- Do’s and don’ts during an inspection
- Top 10 inspection findings
- Preparing for an inspection
- Quiz Time
Qualification
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.
The course provider is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider.
Course Provider
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
