References
- Committee for medicinal products for Human Use. Guideline on risk management systems for medicinal products for human use. 2005.
- European Comission. Volume 9A of the rules governing medicinal products in the European Union. In: Guidelines on pharmacovigilance for medicinal products for human use. 2008.
- Directive 2010/84/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. OJ 2010.
- Comission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parlia. OJ 2012.
- Regulation (EU) No 1235/2010 of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of me. OJ 2010. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF
- Bahri P, Harrison-Woolrych M. Focusing on risk communication about medicines: why now? Drug Saf. 2012;35:971–975.
- Bahri P, Mol PGM, Théophile H, et al. Communication in drug safety: a report from an interactive debate held at the 10th annual meeting of the International Society of Pharmacovigilance (ISoP), 2010. Drug Saf. 2011;34:881–882.
- European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators (Rev 1). 2014.
- European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum I – Educational materials. 2015.
- Prieto L, Spooner A, Hidalgo-Simon A, et al. Evaluation of the effectiveness of risk minimization measures. Pharmacoepidemiol Drug Saf. 2012;21:896–899.
- Banerjee AK, Zomerdijk IM, Wooder S, et al. Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation. Drug Saf. 2014;37:33–42.
- Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, et al. Risk minimization activities of centrally authorized products in the EU: a descriptive study. Drug Saf. 2012;35:299–314.
- European Medicines Agency. European Public Assessment Reports. n.d. [cited 2016 Feb 3]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124
- European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 1). 2014.
- Giezen TJ, Mantel-Teeuwisse AK, Leufkens HGM. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf. 2009;32:811–817.
- Ooba N, Sato T, Watanabe H, et al. Resolving a double standard for risk management of thalidomide: an evaluation of two different risk management programmes in Japan. Drug Saf. 2010;33:35–45.
- Fogg C, Kasliwal R, Shakir SAW. Risk management and outcomes of adverse events to pioglitazone in primary care in the UK: an observational study. Drug Saf. 2009;32:229–237.
- Keddie S. A descriptive study of additional risk minimization measures included in risk management plans reviewed by the United Kingdom regulatory authority. Pharmaceut Med. 2013;27:25–34.
- Goedecke T, Ord K, Newbould V, et al. Medication errors: new EU good practice guide on risk minimisation and error prevention. Drug Saf. 2016;39:491–500.
- International Labour Office. International standard classification of occupations. Geneve:International Labour Organization; 2012.
- Gridchyna I, Cloutier A, Nkeng L, et al. Methodological gaps in the assessment of risk minimization interventions: a systematic review 2014. DOI:10.1002/pds
- Zomerdijk IM, Trifirò G, Sayed-Tabatabaei FA, et al. Additional risk minimisation measures in the EU - are they eligible for assessment? Pharmacoepidemiol Drug Saf. 2013;22:1046–1053.