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Press Release

Two Day The New Arab Pharmacovigilance Guidelines Seminar - Dubai, United Arab Emirates - October 25-26, 2016 - Research and Markets

Research and Markets
Posted on: 01 Sep 16

Research and Markets has announced the addition of the "The New Arab Pharmacovigilance Guidelines" conference to their offering.

The new Arab pharmacovigilance guidelines were issued in May 2015 with their introduction on 1 July 2015. There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application from the perspective of the introduction of the EU guidelines. The course will include experiences of inspections and audits following implementation and will identify what the main focus points will be.


Day One

09.30 An Introduction to the new PV Structure

09:45 Module I - Quality management systems

11.00 Refreshments

11:20 The Pharmacovigilance Systems Master File (PSMF - Module II)

12.45 Lunch

13.45 Pharmacovigilance inspections (Module III)

15.00 Refreshments

15.20 Pharmacovigilance audits (Module IV)

17.00 Close of Day One

Day Two

09.00 Risk Management Plans (RMPs - Module V)

10.15 Module VI - Adverse Reaction Reporting - Part 1

11.15 Refreshments

11:30 Module VI - Adverse Reaction Reporting - Part 2

12.45 Lunch

13.45 PSURs/Module VII

15.15 Refreshments

15.35 Signals and their management (Module IX)

17.00 Final discussion and close of meeting

For more information about this conference visit

Related Topics: Drug Discovery

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Last updated on: 01/09/2016

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