1. Hidalgo-Simon A, Arlett P. Pharmacovigilance in Europe: direction of travel in a changing environment. Expert Rev Clin Pharmacol. 2012;5:485–8.
2. Lumpkin MM, Eichler H-G, Breckenridge A, Hamburg MA, Lönngren T, Woods K. Advancing the science of medicines regulation: the role of the 21st-century medicines regulator. Clin Pharmacol Ther. 2012;92:486–93.
3. Baciu A, Stratton KR, Burke S. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press; 2007. Available at: http://www.nap.edu/catalog/11750/the-future-of-drug-safety-promoting-and-protecting-the-health . Accessed 12 Mar 2015.
4. Office of the Commissioner. FDA strategic priorities: 2014–2018. Silver Spring (MD): Food and Drug Administration; 2014. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htm . Accessed 26 May 2015.
5. Pharmacoepidemiological research on outcomes of therapeutics by a European consortium. PROTECT Home. 2014. Available at: http://www.imi-protect.eu/ . Accessed 21 Jan 2015.