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Regulatory Review: How Do Agencies Ensure the Quality of Decision Making?
Author(s) -
Liberti L,
McAuslane N,
Patel P,
Breckenridge A,
Eichler H G,
Peterson R
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2013.127
Subject(s) - multinational corporation , quality (philosophy) , business , clinical pharmacology , regulatory science , public relations , pharmacology , political science , medicine , finance , pathology , philosophy , epistemology
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. Clinical Pharmacology & Therapeutics (2013); 94 3, 305–308. doi: 10.1038/clpt.2013.127