FDA’s Risk Management Guidance To Be Harmonized With Europe, Japan
Executive Summary
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
You may also be interested in...
European Pharmacovigilance Draft Guidance May Be Released In Summer
A European Medicines Agency draft guideline on "monitoring and inspection of compliance with pharmacovigilance obligations" is under review in preparation for a public consultation
European Pharmacovigilance Draft Guidance May Be Released In Summer
A European Medicines Agency draft guideline on "monitoring and inspection of compliance with pharmacovigilance obligations" is under review in preparation for a public consultation
Risk Management Guidance Suggests Advisory Cmte Review For RiskMAPs
FDA recommends that advisory committees weigh in on whether a risk minimization action plan is appropriate for a particular drug