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| home > white papers > The Impact of Components on Drug Quality and Risk Mitigation - West Pharmaceutical Services, Inc. |
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 WHITE PAPERS |
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West Pharmaceutical Services, Inc.
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The Impact of Components on Drug Quality and Risk Mitigation
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Expectations for quality by regulatory agencies are increasing at a very
fast pace, especially for prefilled drug delivery formats, thanks to
increased focus on reducing risk to patient safety. The trend has
resulted in delays for new drug applications, more recalls of marketed
products and even drug shortages if the container system and drug
contents are suspect for quality issues. The pharmaceutical market is
now requiring manufacturers of containers and components to meet new
expectations with a quality culture and very high product reliability.
The need to bridge the gap and provide superior quality products has
been a driver for manufacturing technology investments, more robust
control strategies and the introduction of next generation elastomer
components.
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News and Press Releases |
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Introducing Signant Health [Formerly CRF Bracket] and the Industry’s Most Comprehensive Patient-Centric Suite for Clinical Research
Philadelphia and London – June 10, 2019: CRF Bracket, formed by the 2018
merger of CRF Health and Bracket, today launched as Signant Health
(signanthealth.com). Uniting eCOA, eConsent, Patient Engagement, IRT,
Clinical Supplies and Endpoint Quality into the industry’s most
comprehensive patient-centric suite, Signant makes it easier to
participate in – and sites and study teams to run – clinical trials.
This intense focus on the patient experience, deep therapeutic area
expertise and global operational scale enable sponsors and CROs to
extend the reach of drug development, expand patient opportunities and
improve data quality.
More info >> |
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White Papers |
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Faster, Better, Cheaper: Lean as a Driving Force Behind Pharmaceutical Companies’ Growth
TBM Consulting Group
The pharmaceutical industry faces countless challenges: patent expirations, weak product development pipelines, downward pricing pressure and an increasingly burdensome regulatory environment. The most important question for companies is now “How can we position ourselves optimally to be successful in the long term?”
Some pharmaceutical companies used the economic downturn in 2009 to embrace measures in the fields of cost reduction and efficiency increases, which can be implemented at short notice. The continuous and consistent implementation of sustainable measures that guarantee stability and form the basis for future growth was not necessarily paramount within this.
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Industry Events |
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PDA Europe Annual Meeting 2019
24 June 2019, Hilton Amsterdam
Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
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