Tuesday, April 23, 2013

What are the new international standards and terminologies for reporting to EudraVigilance?

Highlights of the New Pharmacovigilance Legislation in the EU: Key Pointsto be Taken into Account for Successful Implementation and Lessons Learned
June 23 from 1:00PM – 4:30PM in Boston

This tutorial will focus on the impact of the changes in relation to the new reporting rules and requirements as set out in the Commission’s Implementing Measures and the GVP Modules and the big impact on the operational procedures and the day to day activities of stakeholders. It will also highlight the strengthening of the EudraVigilance System to improve transparency, data quality and to support signal detection and management activities in the EU. In addition, specific emphasis will be placed on informing, explaining and helping stakeholders apply the new rules taking into account the international standardization and harmonization activities and data privacy challenges.

Sabine Brosch, PharmD,PhD
Business Lead, EudraVigilance and International Standardisation in PhV
European Medicines Agency, European Union, United Kingdom

Barton L. Cobert, MD,FACP
BLCMD Associates, LLC, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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