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Press Release

Comprehensive Practical Review of the EU Pharmacovigilance Modules (London, United Kingdom - November 2-3, 2016) - Research and Markets

Research and Markets
Posted on: 04 Oct 16

Research and Markets has announced the addition of the "Comprehensive Practical Review of the EU Pharmacovigilance Modules" conference to their offering.

The 15 new EU modules concerning Pharmacovigilance are a major departure in terms of the way Pharmacovigilance is conducted in Europe. The intention of the course is to look at these modules and their requirements, examine how they overlap and fit together and what Companies need to do in terms of their legal requirements; training; changes and introduction of SOPs; and the links to other Departments - not just Pharmacovigilance but also including Clinical; Medical Information; Marketing; IT; Quality; Regulatory; Training and GMP.

This course will also examine how the new modules have been revised since 2012

  • Gain an Invaluable Overview of the New European PV Legislation and How the 15 Modules Link Together
  • Discover what Key Areas of Pharmacovigilance Activities have been Affected
  • Understand the Impact of the Legislation and what you will need to do to Implement in your Company
  • Discuss the Enforcement of the Legislation and what the Regulators will expect to see at Inspection Time
  • See what NEW Company Departments are Affected Under the New Legislation
  • Follow the changes that have happened in the modules since 2012


Day One

09.30 Quality management - the requirements

10.30 The PSMF

11.30 Refreshments

11.50 Internal audits

13.00 Lunch

14.00 Regulatory Inspections

15.15 Refreshments

15.30 Safety reporting in the EU

16.45 Final discussion and close

Day Two

09.00 Safety reviews & signal detection

10.30 Risk Management Plans

11.00 Refreshments

11.20 Risk benefit analyses

12.30 Lunch

13.30 PSURS/PBRERs in the EU

14.30 Additional monitoring

15.45 Refreshments

16.00 The roles and responsibilities of the MAH

16.30 Close of meeting

For more information about this conference visit

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Business Wire

Last updated on: 04/10/2016

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