European Pharmacovigilance Draft Guidance May Be Released In Summer
Executive Summary
A European Medicines Agency draft guideline on "monitoring and inspection of compliance with pharmacovigilance obligations" is under review in preparation for a public consultation
You may also be interested in...
FDA’s Risk Management Guidance To Be Harmonized With Europe, Japan
Risk management and risk assessment collaboration between the U.S., Europe and Japan will be one of the topics discussed at the International Conference on Harmonization in Brussels, Belgium from May 9-12
EU Drug Applications Will Need Pharmacovigilance Plans In 2005
Pharmaceutical drug marketing applications to the European Medicines Agency will require a pharmacovigilance plan beginning in November 2005
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011