Risk Management-a European Regulatory View

Pharmacovigilance: Second Edition

Volumn , Issue , 2007, Pages 553-558

  Raine, June M ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

ERMS Working Group approach to European Risk Management Strategy; European Centre of Drug Safety Research (ECDS); European pharmaceutical legislation; Risk management European regulatory view; Risk minimisation and pharmacovigilance plan

Indexed keywords

EID: 45849100564     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470059210.ch44     Document Type: Chapter

References (12)

1. CIOMS Working Group VI (2005) Management of Safety Information from Clinical Trials. CIOMS c/o World Health Organisation, Avenue Appia, 1211 Geneva 27. CIOMS@who.int.
2. Directive 2001/83/EC of the European Parliament and of the Council (6 November 2001) Official Journal of the European Communities L-311: 67-128 as amended by (30 April 2004) OJ L-136: 34-57.
3. EMEA (November 2005) CHMP Guideline on Risk Management Systems for Medicinal Products for Human Use. EMEA/CHMP/96268/2005.
4. European Commission G10 Medicines (7 May 2002) Report of High Level Group on Innovation and Provision of Medicines (http://europa.eu.int).
5. Fraunhofer Institute Systems and Innovation Research (March 2006) Assessment of the European Community System of Pharmacovigilance European Commission http://ec.europa.eu/enterprise/pharmaceuticals/pharmacovigilanceacs/index.htm.
6. Heads of Agencies ad hoc Working Group (January 2003) Establishing a European Risk Management Strategy http://heads.medagencies.org/.
7. Heads of Agencies ad hoc Working Group (May 2005) Progress on implementation of the European Risk Management Strategy http://heads.medagencies.org/.
8. Heads of Agencies ad hoc Working Group (January 2006) Overview of pharmacovigilance resources in Europe-survey of national competent authorities http://heads.medagencies.org/.
9. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (November 2004) ICH Harmonised Tripartite Guideline E2E.
10. Lazarou J, Pomeranz BH, Covey PN. Incidence of adverse drug reactions in hospitalised patiensts-a meta-analysis of prospective studies. JAMA 1998; 279: 1200-5.
11. Medicines and Healthcare Products Regulatory Agency (December 2005) Lumiracoxib Post-Launch Enhanced Pharmacovigilance and Risk Management Plan http://www.mhra.gov.uk/home/groups/plp/documents/drugsafetymesage/con2022708.pdf.
12. Pirmohamed M, James S, Meakin S et al. (2004) Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients Br Med J 329: 15-19.