DUBLIN, October 4, 2016 /PRNewswire/ --
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
Agenda
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 http://www.researchandmarkets.com/research/tsjr9n/comprehensive
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Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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