Two-part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates

Are you confident that your Pharmacovigilance operations are meeting the EU’s expectations for compliance?

Did you miss this DIA webinar in July 2012?

Back by popular demand DIA would once again like to provide the pharmaceutical and biotech industry a chance to hear from global experts on the impact of the new Pharmacovigilance legislation that came into effect in July 2012 across the EU as a result of changes set out in:

·         Regulation (EU) No1235/2010 

·         Directive 2010/84/EU 

The legislation was underpinned by an EC Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice. 

The implementation of the new EU legislation is ongoing.  Does your company understand the processes needed to perform adequate benefit-risk assessment? 

This is the webinar your entire Pharmacovigilance team cannot afford to miss. Your product could suffer significant consequences if your company does not have the proper systems and processes in place.  In just two 90 minute sessions attendees will gain a better understanding of how to work to meet EU standards and will be better prepared to implement regulatory requirements for signaling and risk management.  This webinar will also address the new requirements described in the ICH guideline E2C (R2), periodic benefit-risk evaluation report (PBRER).  Periodic Benefit Risk Evaluation Report

This two-part webinar series is designed to give pharmaceutical and biologic companies operating in the EU an introduction to the new European Pharmacovigilance requirements and provide important updates.  The webinars will address the following topics:
Part 1:

• EU regulatory framework
• Ongoing timeframe for implementation of the new legislation
• GVP modules and implementing measures
• PV System Master File (PSMF)
• Audit and inspection
• ADR reporting
• The Pharmacovigilance Risk Assessment Committee (PRAC)

Part 2:

• Risk Management Plans: risk assessment and risk minimization
• Periodic Safety Update Reports/ Periodic benefit-risk evaluation report
• Signal management
• Post authorization studies of safety (PASS) and efficacy (PAES)
• Implications for international harmonization

• Drug safety and Pharmacovigilance
• Regulatory affairs
• Clinical development
• Executives (including C-Level) with any legal responsibility for drug safety
• Benefit-Risk management
• Market Access
• Post-approval studies

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

• Discuss the new EU regulatory requirements for drug safety
• Describe how to process adverse events to meet EU requirements
• Explain what to expect in a European PV inspection
• Describe the differences between the old PSUR and the new PBRER