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
09.30 Quality management - the requirements
10.30 The PSMF
11.50 Internal audits
14.00 Regulatory Inspections
15.30 Safety reporting in the EU
16.45 Final discussion and close
09.00 Safety reviews & signal detection
10.30 Risk Management Plans
11.20 Risk benefit analyses
13.30 PSURS/PBRERs in the EU
14.30 Additional monitoring
16.00 The roles and responsibilities of the MAH
16.30 Close of meeting
For more information about this conference visit http://www.researchandmarkets.com/research/x8fmn8/comprehensive
View source version on businesswire.com: http://www.businesswire.com/news/home/20161004005690/en/Business Wire
Last updated on: 04/10/2016
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