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The new EU legislation for Pharmacovigilance advanced many aspects of Pharmacovigilance to new levels above and beyond the already comprehensive Vol IXa. The legislation is now supported with comprehensive Pharmacovigilance modules that affect Pharmacovigilance; Regulatory; Medical Information; QA; Clinical as well affecting the Senior Management view of Pharmacovigilance requirements and expectations. The 15 new modules are designed to elevate Pharmacovigilance activities to an integrated and risk based assessments of products, processes and how people are trained in the Company to implement both routine Pharmacovigilance as well as implementing processes to minimize and manage Risks to patients.
This course is intended to provide a breakdown of the various modules and provide practical examples of how to perform the various activities what the Regulators want to see for the enhanced Regulatory Inspections that are already occurring.
To understand what needs to be in place practically to perform the various pharmacovigilance activities and how they relate to other Departments in the Company.
This course would be suitable for PV professionals, EU QPPVs, QA & Compliance, Regulatory, Drug Safety and those in the Clinical & Post-marketing arena.
Further information: http://amstadglobal.net/life-science/32/event_details
Article adapted by Medical News Today from original press release. Source:
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Global, Amstad. "EU Pharmacovigilance Legislation & Risk Management November 21-22, 2013, Budapest Hungary." Medical News Today. MediLexicon, Intl., 21 Aug. 2013. Web.
12 Dec. 2013. <http://www.medicalnewstoday.com/releases/265109>
Global, A. (2013, August 21). "EU Pharmacovigilance Legislation & Risk Management November 21-22, 2013, Budapest Hungary." Medical News Today. Retrieved from
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