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Tutorial #4 – Pharmacovigilance System Master File

Jan 12 2014 1:30PM - Jan 12 2014 5:00PM

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Overview 

As part of the new EU Pharmacovigilance Legislation (Regulation EU 1235/2010 and Directive 2010/84/EU) marketing-authorization holders are required to maintain a Pharmacovigilance System Master File (PSMF). The PSMF must be in place at the time of initial marketing authorization application, license renewal and available for inspections. The PSMF replaced the Detailed Description of the Pharmacovigilance System (DDPS). This tutorial will cover the requirements in the PSMF, the creation and maintenance as well as sharing a real experience focusing on some of challenges and how they can be addressed.

Learning Objectives 

At the conclusion of this activity, participants should be able to:

  • Discuss how to prepare a PSMF to meet the requirements
  • Describe how to maintain a PSMF so that it can be available within 7 days from request
  • Examine challenges and possible scenarios of how to address preparation and maintenance

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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