Journal article
Guiding Principles of Safety as a Basis for Developing a Pharmaceutical Safety Culture
Current drug safety, v 2(2), pp 135-139
01 Jan 2007
PMID: 18690959
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.
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Details
- Title
- Guiding Principles of Safety as a Basis for Developing a Pharmaceutical Safety Culture
- Creators
- Brian Edwards - Janssen-CilagAxel K. Olsen - Pharmaceut Safety Inst, Columbia, MD USAMatthew D. Whalen - Pharmaceut Safety Inst, Columbia, MD USAMarla J. Gold - Pharmaceut Safety Inst, Columbia, MD USA
- Publication Details
- Current drug safety, v 2(2), pp 135-139
- Publisher
- Bentham Science Publ
- Number of pages
- 5
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Infectious Diseases (and HIV Medicine)
- Web of Science ID
- WOS:000218205600005
- Scopus ID
- 2-s2.0-34249278798
- Other Identifier
- 991019302020204721
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- Collaboration types
- International collaboration
- Web of Science research areas
- Pharmacology & Pharmacy