Tutorial name:#31: Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned
Day & Time:June 23, 1:00PM - 4:30PM
Instructor(s):Sabine Brosch, PharmD,PhD
Business Lead, EudraVigilance and International Standardisation in PhV
European Medicines Agency, European Union, United Kingdom
Barton L. Cobert, MD,FACP
President
BLCMD Associates, LLC, United States
Description:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 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.Following publication of the new pharmacovigilance legislation in December 2010, the Commission’s Implementing Measures for the performance of pharmacovigilance activities and the Good Pharmacovigilance Practices (GVP) replacing Volume 9A bring significant changes to the conduct of pharmacovigilance. Furthermore, the new ICH Individual Case Safety Report (ICSR) Implementation Guide will introduce substantial modifications to the format and content of electronic adverse reaction reporting. These changes have a big impact on the operational procedures and the day to day activities of stakeholders working in pharmacovigilance. 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. 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.
| #31: Highlights of the New PV Legislation in EU | CME
IACET
| 3.25
3.25
| 0.000
0.300
|
Learning Objective(s):At the conclusion of this tutorial, participants should be able to:
• Discuss the adverse reaction reporting rules described in the new pharmacovilance legislation
• Describe the new international standards and terminologies for reporting to EudraVigilance
• Describe the obligations for marketing authorization holders regarding signal detection and management.
Target Audience:This tutorial is designed for qualified persons responsible for pharmacovigilance staff involved in:
• pharmacovigilance in companies and national competent authorities
• clinical data management
• regulatory intelligence
• information management
• safety databases