Pharmacovigilance activities in the United States, European Union and Japan: harmonic convergence or convergent evolution?
Faden
Laura B
LB
Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, USA.
Milne
Christopher-Paul
CP
D016903:Drug Monitoring / Q000379:methods*; D005062:European Union; D033161:Government Regulation; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D038622:Internationality / Q000331:legislation & jurisprudence*; D007564:Japan; D017891:Pharmacoepidemiology / Q000331:legislation & jurisprudence* / Q000379:methods; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000379:methods*; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration