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

Jun 15 2014 9:00AM - Jun 15 2014 5:00PM | San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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Overview 

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Learning Objectives 

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.

Instructor(s) 

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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