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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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Nemera acquires Insight Product Development to strengthen its capabilities
“Every day at Nemera, we work to improve the lives of millions of patients worldwide by designing, developing and manufacturing innovative drug delivery devices. Our vision as a team is to become the most patient-centric drug delivery device company in the industry. We partner closely with our customers to deliver innovative and high quality devices, to ensure that patients will receive the best product and service possible” Marc Hämel, CEO
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White Papers |
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Finding the Right End-to-End Safety Solution for Your Needs
Bioclinica
With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
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Industry Events |
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ESMO Targeted Anticancer Therapies Congress 2020
2-4 March 2020, Paris, France
A unique and international mix of experts, researchers and decision
makers both from academia and industry across the globe, will convene
in Paris for a three-day Congress aiming at exchanging knowledge,
experience and research innovations in cancer.
TAT
2020 will focus, among others, on novel strategies in immuno-oncology,
personalised medicine and molecular tumour boards, preclinical studies
to identify effective combination therapies, use of microbiome, tumour
agnostic trials, ADC technology, oncolytics, multispecific biological
constructs and targeting cytokines.
Participating in TAT 2020 will offer you the possibility to take part in
interdisciplinary discussions inspiring new ideas and new
collaborations.
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