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Bioclinica

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Finding the Right End-to-End Safety Solution for Your Needs

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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News and Press Releases

PCI and CSP Technologies, Inc. Announce Strategic Collaboration for Breakthrough Activ-BlisterTM Solutions

Philadelphia, PA & Auburn, AL – September 17, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce its exclusive collaboration agreement with CSP Technologies, Inc. for U.S. clinical trials and stability testing utilizing Activ-BlisterTM packaging solutions, which help protect and promote speed-to-market for pharmaceutical and medical device products with heightened susceptibility to moisture and gases, especially oxygen.
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White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
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Industry Events

RDD Asia 2018

14-15 November 2018, Grand Hyatt Kochi, Kerala, India

A must-attend meeting for pulmonary and nasal researchers, inhaled product developers and vendors active in this important pharmaceutical niche.
More info >>


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