title: Drug-induced PML: a global agenda for a global challenge.
abstract: The occurrence of severe adverse events such as progressive multifocal leukoencephalopathy (PML) has the potential to limit the benefits of highly efficacious medicines being developed to fulfill unmet clinical needs across therapeutic areas. Following an Expert meeting in London in July 2011 (http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500111562.pdf), a research agenda, highlighting methodological, clinical, and communication elements, to mitigate the risk and improve the management of drug-induced PML has been agreed upon.
authors.affiliation: Pharmacovigilance and Risk Management Sector, European Medicines Agency, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Vinhas de Souza
authors.forename: B
authors.initials: B
authors.lastname: Keller-Stanislawski
authors.forename: K
authors.initials: K
authors.lastname: Blake
authors.forename: A
authors.initials: A
authors.lastname: Hidalgo-Simon
authors.forename: P
authors.initials: P
authors.lastname: Arlett
authors.forename: G
authors.initials: G
authors.lastname: Dal Pan
mesh_terms: D000818:Animals; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects; D014943:Global Health / Q000592:standards*; D006801:Humans; D007968:Leukoencephalopathy, Progressive Multifocal / Q000139:chemically induced* / Q000453:epidemiology* / Q000517:prevention & control; D008131:London; D000069442:Natalizumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab