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#46: The Good Pharmacovigilance Practices In The EU: Lessons Learned and Frequently Asked Implementation Questions

Tutorial name:
#46: The Good Pharmacovigilance Practices In The EU: Lessons Learned and Frequently Asked Implementation Questions

Day & Time:
June 15, 9:00AM - 5:00PM (Pacific Standard Time)

Room Number:
7B

Description:
Maximize your learning while attending the DIA 2014 50th Annual Meeting! Receive $100 off of your DIA 2014 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.

The Good Pharmacovigilance Practices (GVP) modules, together with the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities published in 2012, promote and protect public health by strengthening the European system for monitoring the safety and use of medicines. This framework provides important technical and operational details that need to be taken into account by marketing authorization holders in the daily practice of applying the new legislation.

This tutorial will provide a forum for stakeholders to hear about the achievements and implementation experience in relation to the new pharmacovigilance legislation and to address stakeholder questions. Key topics addressed will include pharmacovigilance and quality systems, the implementation of the pharmacovigilance system master file (PSMF), adverse reaction reporting principles, Periodic Safety Update Report (PSUR) synchronization and work sharing, signal management and new aspects in benefit-risk management.

Target Audience:
This tutorial is designed for professionals who work in clinical development, information management, pharmacovigilance, and safety databases.