#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:
Sabine Brosch, PharmD, PhD
Monitoring and Incident Management, Pharmacovigilance
European Medicines Agency, European Union, United Kingdom
Saad A.W. Shakir, MD, FFPM, FISPE, FRCP
Drug Safety Research Unit (DSRU), United Kingdom
Steve Jolley, MA
Chief Executive Officer
SJ Pharma Consulting, LLC, United StatesDescription: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.
|#46: The Good Pharmacovigilance Practices In The E||CME|
At the conclusion of this tutorial, participants should be able to:
- Define the new pharmacovigilance legislation, overall achievements and lessons learned;
- Discuss key areas of the Good Pharmacovigilance Practices guidelines and further developments;
- Identify the preparation for the implementation of the simplified adverse reaction reporting rules and the new ISO ICSR/ICH E2B(R3) standard with main focus on EU specific requirements;
- Discuss requirements in adverse reaction reporting with main focus on post-authorization studies and patient support programs;
- Discuss the principles of PSUR synchronization and work sharing;
- Discuss signal management activities;
- Describe key principles applied in risk management;
- Discuss the implications of the new requirements for US and other non-EU based companies.
This tutorial is designed for professionals who work in clinical development, information management, pharmacovigilance, and safety databases.