Tuesday, February 28, 2012

EMA Updates Drug Safety Policies for the First Time since 1985

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The EMA has recently announced it will be targeting pharmacovigilance in Europe.  This will impact the framework of of the EMA for the first time since 1995, and will improve the safety risk-benefit monitoring of drugs.  BioPharm International recently reported on the new legislation.

What are the four focuses of this legislation?
  • - Collection of key medicines’ information - This focus will make it easier to make drug safety and efficacy studies up to date.  It will also allow patient to report on side effects they may be experiencing from the drugs.  
  • - Better analysis and understanding of data and information: New IT systems will make it easier to collect and analyze the side effects collection system.
  • - Regulatory action to safeguard public health: A new risk assessment committee will begin meeting in July to begin planning, assessing and monitoring issues created by medicine that will influence the new system Urgent Union Procedure.
  • - Communication with stakeholders:  In an effort to bring transparency to their system, they will begin to publish all of these things online.
Next week, at the 21st Annual Partnerships in Clinical Trials, the implications of these changes will be discussed at the Clinical Drug Safety Summit at Partnerships.  For more information on this Summit, download the brochure.  If you'd like to join us next Monday for the Summit, register and mention code XP1700BLOG to save 15% off the standard rate.  If you have any questions, feel free to email Jennifer Periera.

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