Developing Global Solutions for Product Safety

Oct 10, 2017

Over the past 20 years, the level of globalisation in the pharmaceutical industry increased significantly for both innovative and generic drugs. Magdalena Matusiak, Associate Director, Quality Assurance & Compliance at KCR, analyses how international cooperation between regulatory bodies and the harmonisation of regulatory requirements are key elements supporting the effective development of medicines. ...

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Globalising Clinical Trials

Oct 10, 2017

Pharmaceutical companies are increasingly embracing the need for running trials across multiple sites globally. The rise of personalised medicine, and its promise of improving the drug development process and focused, faster approval of new therapies, places the industry firmly at the centre of the global genomics initiative. Rodrigo Barnes, Chief Technology Officer and Pamela Brankin, Head of Marketing and Communications at Aridhia Informatics Ltd, observe how capitalising on it requires a combination of technologies supported and enabled by increased collaboration among the industry, academia and healthcare providers. ...

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What Clinical Teams Should Know about Changing Trial Logistics and How they will Affect Development – PART 1

Oct 10, 2017

When it comes to clinical supplies, the journey is every bit as important as the destination. And these days, the journey of clinical supplies to investigator sites is becoming costlier and more complex, much like the global trials for which the materials are bound. In addition to discussing how supply logistics are changing, this paper by Jennifer Worsfold, Senior Director Supply Chain Solutions at Fisher Clinical Services, shows how clinical services are deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies. ...

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Serious About Tarmac Time

Oct 10, 2017

Temperature excursions during loading and unloading procedures of air-freight shipments (so called ‘tarmac times’) of pharmaceutical products represent a major challenge for a fully controlled cool chain. The standard solution in the industry for this problem is thermal blankets. In this piece, Dr Florian Siedenburg, General Manager of ECOCOOL GmbH, looks into the challenge of providing increased thermal protection for low-mass pallets of pharmaceutical goods. ...

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Coding Ensures Safe Food Produce

Oct 10, 2017

In the pharmaceuticals industry, the coding of medicinal products is governed by directives in many countries. However, Track & Trace is also gaining ground in the food industry. Indeed, products are labelled in such a way that they can be traced on their way through the entire supply chain. The necessary coding solutions form part of the packaging process and therefore need to be integrated into existing packaging guidelines, says Axel Jung, Product Manager for Laetus Track & Trace Systems. ...

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