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Websites
- European Medicine Agency. CHMP recommendations for the pharmacovigilance plan as part of the risk management plan to be submitted with the marketing authorisation application for a pandemic influenza vaccine www.emea.europa.eu/pdfs/human/pandemicinfluenza/35938109en.pdf
- CIOMS-WHO working group on vaccine pharmacovigilance. Definition of vaccine pharmacovigilance www.cioms.ch/finalvpvdef.pdf
- The Brighton Collaboration www.brightoncollaboration.org
- European Medicine Agency. CHMP recommendations for the core risk management plan for influenza vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context. www.emea.europa.eu/pdfs/human/pandemicinfluenza/4999308en.pdf
- US FDA. Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials www.fda.gov/BiologicsBloodVaccines/guidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074775.htm
- WHO. Adverse events following immunization (AEFI). Causality assessment http://whqlibdoc.who.int/aide-memoire/a87773_eng.pdf
- Treaty establishing the European community http://eur-lex.europa.eu/en/treaties/index.htm#founding
- Regulation (EC) number 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European centre for disease prevention and control http://ecdc.europa.eu/en/aboutus/Key%20Documents/0404_KD_Regulation_establishing_ECDC.pdf
- EudraLex – Volume 9A Pharmacovigilance for Medicinal Products for Human Use http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9a_09–2008.pdf
- Committee for medicinal products for human use. Guidelines on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases www.emea.europa.eu/pdfs/human/phvwp/50344907enfin.pdf
- Authorisation and supervision of medicinal products – European Medicines Agency Link
- Global Advisory Committee on Vaccine Safety (GACVS) www.who.int/vaccine_safety/en/
- European strategy for influenza A/H1N1 vaccine benefit–risk monitoring www.emea.europa.eu/pdfs/human/pandemicinfluenza/european_strategy.pdf
- VENICE II project http://venice.cineca.org
- VAESCO project www.vaesco.net
- CIOMS. Development and rational use of standardised MedDRA queries (SMQs) www.cioms.ch/frame_meddra_queries_oct_2004.htm