Areas Covered in the Session: Overview of EU Regulatory structure EU Pharmacovigilance : Why make changes now? New definitions for the updated directive and regulation Organization of PV Modules Update to the EU Pharmacovigilance legislation How the new legislation will better protect patient safety How the new legislation will affect Marketing Authorization Holders How the new legislation will affect Sponsors of Clinical Studies Adverse Drug Reaction Reporting Periodic Safety Update Reports Post-Authorization Safety Studies Eudravigilance Database Changes to labeling The Pharmacovigilance Risk Assessment Committee Implementation timing & expectations

Date : 10th December 2014 to 10th December 2014

Place : United States, Online event

Website :http://bit.ly/1GUZ7Oz

Contact Person:Adam Fleming

Description:

Areas Covered in the Session: Overview of EU Regulatory structure EU Pharmacovigilance : Why make changes now? New definitions for the updated directive and regulation Organization of PV Modules Update to the EU Pharmacovigilance legislation How the new legislation will better protect patient safety How the new legislation will affect Marketing Authorization Holders How the new legislation will affect Sponsors of Clinical Studies Adverse Drug Reaction Reporting Periodic Safety Update Reports Post-Authorization Safety Studies Eudravigilance Database Changes to labeling The Pharmacovigilance Risk Assessment Committee Implementation timing & expectations

Areas Covered in the Session: Overview of EU Regulatory structure EU Pharmacovigilance : Why make changes now? New definitions for the updated directive and regulation Organization of PV Modules Update to the EU Pharmacovigilance legislation How the new legislation will better protect patient safety How the new legislation will affect Marketing Authorization Holders How the new legislation will affect Sponsors of Clinical Studies Adverse Drug Reaction Reporting Periodic Safety Update Reports Post-Authorization Safety Studies Eudravigilance Database Changes to labeling The Pharmacovigilance Risk Assessment Committee Implementation timing & expectations will be held in Online event,United States on date 2014-12-10

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Deadline for abstracts/proposals : 8th December 2014

Keynote Speakers :

Check the event website for more details.