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  Events - January 2013


3rd Annual Pharmacovigilance and Risk Management Strategies

24 Jan 2013 - 25 Jan 2013 - Madrid, Spain



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This 2-day event will bring together expert minds from the Danish Medicines Agency, the Dutch Medicines Evaluation Board, and Spanish Medicines Agency but also from TOP companies like GSK Biologicals, Novartis Pharma, Sanofi, Bristol-Myers Squibb.., to examine the Pharmacovigilance areas of key concern:

  • Insights into new features and key changes introduced by the new PV legislation and its implementation (RMPs, safety reporting, PASS/PAES, etc.)
  • Industry experience with the new ICH-E2C guideline on periodic safety reporting (plus the harmonisation of the EU and US safety reports)
  • PV developments outside the ICH region (Brazil, India)
  • Creation of a successful and cost-effective PV system in the frame of the new legislation
  • Effectiveness of risk minimisation and establishing monitoring system
  • PV in special populations (pregnant & elderly)




Further information
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Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
New Medication Shows Promise Against Liver Fibrosis in Animal Studies
Liver fibrosis is a gradual scarring of the liver that puts people at risk for progressive liver disease and liver failure.
Raw Eggs Deemed Safe to Eat
A report published today by the Advisory Committee on the Microbiological Safety of Food (ACMSF) into egg safety has shown a major reduction in the risk from salmonella in UK eggs.
Monitoring TTX Toxin in Shellfish
In a number of small studies, mussels and oysters from the eastern and northern part of the Oosterschelde in Holland were found to contain tetrodotoxin (TTX).
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Gene-Editing 'Toolbox' Targets Multiple Genes Simultaneously
Researchers have designed a system that modifies, or edits, multiple genes in a genome at once while minimising unintentional effects.
Detecting Alzheimer's with Smell Test
Odour identification test may offer low-cost alternative for predicting cognitive decline and detecting early-stage Alzheimer’s disease.
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