Signal Detection and Data Mining in Pharmacovigilance - Webinar By GlobalCompliancePanel

Signal Detection and Data Mining in Pharmacovigilance - Webinar By GlobalCompliancePanel

Overview: This webinar will cover the fundamentals of signal detection, and how these can be augmented by the use of data mining techniques.

In March 2005, the FDA published final guidance on "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." This guidance defines the FDA's views on pharmacovigilance concepts, safety signal identification, pharmacoepidemiologic assessment and interpretation of safety signals.This webinar will demonstrate how to meet FDA's requirements for detection of potential signals or trends.

Why should you attend: The requirement for companies to perform signal detection is now mandatory in Europe and highly recommended in the US.

The FDA Amendment Act mandates that companies develop Risk Evaluation and Mitigatiuon Strategies for their products, where required.In order to assess a product's risk-benefit profile it is essential that companies perform signaling analyses based on all available safety data for their products.

The requirement for companies to perform signal detection is now mandatory in Europe and highly recommended in the US.

The FDA Amendment Act mandates that companies develop Risk Evaluation and Mitigatiuon Strategies for their products, where required.In order to assess a product's risk-benefit profile it is essential that companies perform signaling analyses based on all available safety data for their products.

Areas Covered in the Session:

Analysis of demographics, risk assessment, dose effects, product-product interactions, and differences from known background rates

Strategies for incorporating all relevant data sources, including clinical trials, individual case reports, PSURs, external databases (FDA, WHO), and registries

Understanding the risk-benefit ratio of a product and how to discover product-adverse event relationships

Measuring the strength of the relationship of the adverse event and the drug using the Bayesian Confidence Propagation Neural Network algorithm (BCPNN)

Who Will Benefit:

Drug safety and pharmacovigilance

Regulatory Affairs

Clinical development

http://www.articlesbase.com/business-articles/signal-detection-and-data-mining-in-pharmacovigilance-webinar-by-globalcompliancepanel-3695966.html

POST COMMENT

The Global Market For Advanced Airport Technologies Global Gem & Jewelry Market Report - 2010 Edition - Market Research Report On Aarkstore Enterprise For What Hotels in India are globally known – Know the Fact Top 5 Benefits Of Using Global Sim Cards And 3g Data Cards B2B Online Marketing: Reach the Global B2B Community from Your Desktop Global Health Progress Commends European Union And India Agreement Increasing Access To Drugs In Dev Litera Achieves Record Customer Growth For Global Document Lifecycle Management Solutions A Few Considerations when Purchasing a Long Term Care Policy Globalization's Impact on the Accounting Profession CHALLENGES INVOVLED IN MANAGING LARGE AMOUNT OF CORRUGATED SHIPPING CONTAINERS Four Questions About How Local Clothing Brands Touch The Global Market? - Local Clothing Market - Antidote to Globalists' Threat to U.S. Dollar-Gold Investments FOEX Indexes and Wood Resources International to partner in the launching of Global Wood Chip Price Indices