A Descriptive Study of Additional Risk Minimization Measures Included in Risk Management Plans Reviewed by the United Kingdom Regulatory Authority-Reference-Cited by-同舟云学术

A Descriptive Study of Additional Risk Minimization Measures Included in Risk Management Plans Reviewed by the United Kingdom Regulatory Authority

Published:2013-01-23 Issue:1 Volume:27 Page:25-34
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Keddie Sophie

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/s40290-013-0006-6.pdf

Reference27 articles.

1. Shakir S. Prescription-event monitoring. In: Strom BL, editor. Pharmacoepidemiology. 4th ed. Philadelphia: Wiley; 2005. p. 203–16.

2. Edwards I, Olsson S, Lindquist M, et al. Global drug surveillance: the WHO programme for international drug monitoring. In: Strom BL, editor. Pharmacoepidemiology. 4th ed. Philadelphia: Wiley; 2005. p. 161–85.

3. EMA. CHMP guideline on risk management systems for medicinal products for human use. London: European Medicines Agency; 2005.

4. The Human Medicines Regulations 2012 no. 1916. Part 11 (2012). http://www.legislation.gov.uk/uksi/2012/1916/part/11/made . Accessed 1 Nov 2012.

5. Regulation (EC) No. 1235/2010 of the European Parliament Council. Of 15 December 2010. Regulation (EC) No 726/2004 and Regulation (EC) No 1394/2007.

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