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Clin Pharmacol Ther. 2013 Sep;94(3):305-8. doi: 10.1038/clpt.2013.127.

Regulatory review: How do agencies ensure the quality of decision making?

Author information

1
Centre for Innovation in Regulatory Science, London, UK. Lliberti@cirsci.org

Abstract

The Centre for Innovation in Regulatory Science (CIRS) Workshop on Regulatory Review brought together international regulators and multinational pharmaceutical company representatives to focus on best practices that underlie regulatory decision making, thereby facilitating the transparent, timely, procedurally predictable, and good-quality evaluation of new medicines. Participants investigated frameworks used by agencies, discussed challenges for regulatory agencies in making quality decisions, investigated the role of other stakeholders, and made recommendations of activities and processes that agencies and companies can consider to enable quality decision making.

PMID:
23963218
DOI:
10.1038/clpt.2013.127
[Indexed for MEDLINE]

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