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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)




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