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Items: 1 to 20 of 131

1.
2.

Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.

Borg JJ, Aislaitner G, Pirozynski M, Mifsud S.

Drug Saf. 2011 Mar 1;34(3):187-97. doi: 10.2165/11586620-000000000-00000. Review.

PMID:
21332243
3.

Allergic reactions to Japanese encephalitis vaccine.

Plesner AM.

Immunol Allergy Clin North Am. 2003 Nov;23(4):665-97. Review. Erratum in: Immunol Allergy Clin North Am. 2004 May;24(2):335.

PMID:
14753386
4.

The Internet and drug safety: what are the implications for pharmacovigilance?

Cobert B, Silvey J.

Drug Saf. 1999 Feb;20(2):95-107. Review.

PMID:
10082068
5.

Issues with regulatory pharmacovigilance in East European countries: the industry perspective.

Hanzl-Dujmović I, Sulić-Milisić Z, Staresinić-Sernhorst I.

Toxicol Lett. 2007 Feb 5;168(3):228-35. Epub 2006 Nov 16. Review.

PMID:
17161561
6.

European pharmacovigilance: increasingly outsourced to drug companies.

[No authors listed]

Prescrire Int. 2014 Dec;23(155):302-3, 305-7.

PMID:
25629153
7.

Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

Hartford CG, Petchel KS, Mickail H, Perez-Gutthann S, McHale M, Grana JM, Marquez P.

Drug Saf. 2006;29(8):657-73. Review.

PMID:
16872240
8.

[Risk communication with patients].

Hirose M.

Yakugaku Zasshi. 2012;132(5):561-2. Review.

9.

Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys.

Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, Hazell L, Krska J, Lee AJ, McLernon DJ, Murphy E, Shakir S, Watson MC.

Health Technol Assess. 2011 May;15(20):1-234, iii-iv. doi: 10.3310/hta15200. Review.

10.

Risk management frameworks for human health and environmental risks.

Jardine C, Hrudey S, Shortreed J, Craig L, Krewski D, Furgal C, McColl S.

J Toxicol Environ Health B Crit Rev. 2003 Nov-Dec;6(6):569-720. Review.

PMID:
14698953
11.

The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation.

Pignatti F, Gravanis I, Herold R, Vamvakas S, Jonsson B, Marty M.

Clin Cancer Res. 2011 Aug 15;17(16):5220-5. doi: 10.1158/1078-0432.CCR-11-0623.

12.

CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.

Tsintis P, La Mache E.

Drug Saf. 2004;27(8):509-17. Review.

PMID:
15154824
13.
14.

Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.

Tomić S, Sucić AF, Martinac AI.

Regul Toxicol Pharmacol. 2010 Jul-Aug;57(2-3):325-32. doi: 10.1016/j.yrtph.2010.04.001. Epub 2010 Apr 10.

PMID:
20385190
15.

The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.

Morrato EH, Ling SB.

Med Care. 2012 Nov;50(11):970-86. doi: 10.1097/MLR.0b013e31826c872d.

PMID:
23047787
16.

[Improving drug safety in Germany: an alliance between the government and the medical profession].

Müller-Oerlinghausen B, Ludwig WD.

Z Evid Fortbild Qual Gesundhwes. 2008;102(9):582-6; discussion 593, 606-8. German.

PMID:
19213455
17.

European Union pharmacovigilance capabilities: potential for the new legislation.

Borg JJ, Tanti A, Kouvelas D, Lungu C, Pirozynski M, Serracino-Inglott A, Aislaitner G.

Ther Adv Drug Saf. 2015 Aug;6(4):120-40. doi: 10.1177/2042098615591802. Review.

19.

New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS).

Shin JY, Jung SY, Ahn SH, Lee SH, Kim SJ, Seong JM, Chung SY, Park BJ.

Pharmacoepidemiol Drug Saf. 2014 Nov;23(11):1115-22. doi: 10.1002/pds.3715. Epub 2014 Sep 24.

PMID:
25251052
20.

Efaproxiral: GSJ 61, JP 4, KDD 86, RS 4, RSR 13.

[No authors listed]

Drugs R D. 2005;6(3):178-85. Review.

PMID:
15869322
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