DUBLIN--(BUSINESS WIRE)--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.
Agenda
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 http://www.researchandmarkets.com/research/gndpd2/the_new_arab
Related Topics: Drug Discovery
