[Novel therapeutics risk management].
The identification and assessment of risks, in particular, of new or innovative medicines, as well as risk mitigation are the most important tasks of pharmacovigilance. Pharmacovigilance activities should abide by the 'precautionary principle'. Risk management plans are a new tool for achieving this goal. The key elements of risk management plans include a drug-specific risk specification, a pharmacovigilance plan as well as appropriate risk communication procedures.
Hagemann
Ulrich
U
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn. hagemann@bfarm.de
D016265:Conflict of Interest; D004345:Drug Industry / Q000941:ethics; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D012307:Risk Factors; D012308:Risk Management / Q000379:methods* / Q000592:standards
D004364:Pharmaceutical Preparations