title: Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
abstract: On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.
authors.affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, 20993, USA, lawrence.yu@fda.hhs.gov.
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Baker
authors.forename: Susan C
authors.initials: SC
authors.lastname: Berlam
authors.forename: Ashley
authors.initials: A
authors.lastname: Boam
authors.forename: E J
authors.initials: EJ
authors.lastname: Brandreth
authors.forename: Lucinda
authors.initials: L
authors.lastname: Buhse
authors.forename: Thomas
authors.initials: T
authors.lastname: Cosgrove
authors.forename: David
authors.initials: D
authors.lastname: Doleski
authors.forename: Lynne
authors.initials: L
authors.lastname: Ensor
authors.forename: Joseph
authors.initials: J
authors.lastname: Famulare
authors.forename: Mohan
authors.initials: M
authors.lastname: Ganapathy
authors.forename: Gustavo
authors.initials: G
authors.lastname: Grampp
authors.forename: David
authors.initials: D
authors.lastname: Hussong
authors.forename: Robert
authors.initials: R
authors.lastname: Iser
authors.forename: Gordon
authors.initials: G
authors.lastname: Johnston
authors.forename: Filippos
authors.initials: F
authors.lastname: Kesisoglou
authors.forename: Mansoor
authors.initials: M
authors.lastname: Khan
authors.forename: Steven
authors.initials: S
authors.lastname: Kozlowski
authors.forename: Emanuela
authors.initials: E
authors.lastname: Lacana
authors.forename: Sau L
authors.initials: SL
authors.lastname: Lee
authors.forename: Stephen
authors.initials: S
authors.lastname: Miller
authors.forename: Sarah Pope
authors.initials: SP
authors.lastname: Miksinski
authors.forename: Christine M V
authors.initials: CM
authors.lastname: Moore
authors.forename: Theresa
authors.initials: T
authors.lastname: Mullin
authors.forename: G K
authors.initials: GK
authors.lastname: Raju
authors.forename: Andre
authors.initials: A
authors.lastname: Raw
authors.forename: Susan
authors.initials: S
authors.lastname: Rosencrance
authors.forename: Mark
authors.initials: M
authors.lastname: Rosolowsky
authors.forename: Paul
authors.initials: P
authors.lastname: Stinavage
authors.forename: Hayden
authors.initials: H
authors.lastname: Thomas
authors.forename: Russell
authors.initials: R
authors.lastname: Wesdyk
authors.forename: Joerg
authors.initials: J
authors.lastname: Windisch
authors.forename: Sivakumar
authors.initials: S
authors.lastname: Vaithiyalingam
mesh_terms: D017277:Drug Approval; D015195:Drug Design; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations
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