title: Regulatory review: How do agencies ensure the quality of decision making?
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.
authors: Centre for Innovation in Regulatory Science, London, UK. Lliberti@cirsci.org
authors: L
authors: L
authors: Liberti
authors: N
authors: N
authors: McAuslane
authors: P
authors: P
authors: Patel
authors: A
authors: A
authors: Breckenridge
authors: H G
authors: HG
authors: Eichler
authors: R
authors: R
authors: Peterson
mesh_terms: D003659:Decision Making, Organizational; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D006077:Government Agencies; D033161:Government Regulation; D017149:Private Sector / Q000331:legislation & jurisprudence / Q000458:organization & administration