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International Clinical Trials

Keeping Track

As the global pharmaceutical industry implements serialisation to meet governmental regulatory requirements, other opportunities exist for companies to realise business benefits. The main driver for serialisation is to provide greater integrity to the supply chain, but other meaningful advantages can also be obtained.

Combatting Counterfeits

In addition to tightening up the supply chain and channels of trade, serialisation can provide great efficiencies for processing shipments and knowing what specific packages are included in shipments down to the lowest saleable unit. Tracking information can be updated continuously and provided to brand owners and supply chain partners on dashboards or on mobile applications.

These developments in enhanced track and trace can be employed to more quickly and accurately detect diversion of product to unauthorised regions. To combat counterfeiting, new authentication technologies now exist for linking serial numbers to security features that are unique to each package to detect possible replication of serial numbers by counterfeiters.

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Steve Wood is the President and Chief Executive Officer (CEO) of Covectra and holds a Bachelor of Science degree from the US Naval Academy and an MBA from Yale, US. He has over 25 years of experience in processing and packaging machinery, pharma security technologies and integrated systems. Steve is the co-founder/CEO of five different companies and is currently serving as Director of PharmoRx Therapeutics and MedSentry.
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Steve Wood
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News and Press Releases

YHEC announces the promotions of Michelle Jenks and Rachael McCool to the role Project Director

YHEC is pleased to announce the promotions of Michelle Jenks from the Economic Modelling team and Rachael McCool from the Systematic Reviewing team to the role Project Director. Michelle has a Master’s degree (MSc) in health economics from the University of York and has conducted economic evaluations and systematic reviews for both public and private sector clients. Michelle is the lead modeller in YHEC’s role as an External Assessment Centre for NICE and has also led on a range of economic evaluations conducted for clients within industry, such as cost-utility models and budget impact models. She often leads the development of early economic analyses to inform clinical trial design and pricing strategy.
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White Papers

Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control

Berlinger & Co AG

There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
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Industry Events

14th Annual Biomarkers & Immuno-Oncology World Congress

11-13 June 2018, Westin Boston Waterfront, Boston, Massachusetts

The Biomarkers and Immuno-Oncology World Congress brings together a unique and international mix of large and medium pharmaceutical, biotech and diagnostics companies, leading universities and clinical research institutions, government and national labs, CROs, emerging companies and tool providers—making the Congress a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies.
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