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Tutorial #4 – Pharmacovigilance System Master File

Tutorial name:
Tutorial #4 – Pharmacovigilance System Master File

Day & Time:
January 12, 1:30PM - 5:00PM

Registration Fees
- Tutorial #4 Rate$405.00

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.

EventCredit TypeMax CreditsCEU
Tutorial #4 – Pharmacovigilance System Master FiIACET

Learning Objective(s):

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