title: Expediting patients' access to medicines by improving the predictability of drug development and the regulatory approval process.
abstract: Ideally, well-designed global pharmaceutical development programs that include simultaneous submissions to multiple regulatory agencies can result in predictable regulatory approvals and expedited access to medicines for all patients. The workshops described herein investigated current trends in development and submission strategies along with regulatory review performance data in order to consider whether barriers to predictable expedited approval outcomes can be overcome through innovative clinical development approaches and a better understanding of review processes and procedures, particularly as these relate to the assessment of a product's risk-benefit profile.
authors.affiliation: Centre for Medicines Research International Institute for Regulatory Science, London, UK. lliberti@cmr.org
authors.forename: L
authors.initials: L
authors.lastname: Liberti
authors.forename: A
authors.initials: A
authors.lastname: Breckenridge
authors.forename: H G
authors.initials: HG
authors.lastname: Eichler
authors.forename: R
authors.initials: R
authors.lastname: Peterson
authors.forename: N
authors.initials: N
authors.lastname: McAuslane
authors.forename: S
authors.initials: S
authors.lastname: Walker
mesh_terms: D004219:District of Columbia; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000600:supply & distribution; D011237:Predictive Value of Tests; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence* / Q000379:methods; D006113:United Kingdom
chemical_list: D004364:Pharmaceutical Preparations