Brexit and beyond: your guide to OECD Mutual Acceptance of Data

March 7, 2019

It’s no secret that Brexit is weighing heavily on everybody’s minds at the moment. One of the major questions being asked in our industry is “how will Brexit affect the acceptance of non-clinical study data?”. In this blog post you’ll get our fully-informed answer.We start with an overview of the OECD, and a summary of a recent public statement from the Medicines and Healthcare Products Regulatory Agency (MHRA). We cover the acceptance of Good Laboratory Practice (GLP) worldwide data from UK labs. Plus, you’ll hear from Envigo’s Chief Scientific Officer, Lee Coney, on the recent news. (Spoiler alert: if you’re an Envigo customer, you have nothing to worry about.)

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Versalis SpA

Production and commercialization of polyethylene, base chemicals, polystyrene and elastomers. Based in Italy, has production sites in Italy, Germany, France, UK and Hungary. The European network is handled by Versalis International based in Brussels, Belgium.

OTHER ARTICLES

Transporting biological and chemical materials - what you need to know

Article | February 13, 2020

The landscape of biological and chemical logistics has changed rapidly - as have the regulatory frameworks around it. What has not necessarily kept pace is the end-user understanding of the nature of these logistical processes, their opportunities and their constraints. Twenty years ago, the transmission of biological and chemical materials was limited to a small range of organisations: usually national and international research companies, hospitals, major university departments, police and military departments with forensic responsibilities.

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Setting record straight on testing harm in chemicals

Article | February 13, 2020

The modern world is built on chemicals, be it the medicines we use, or cleaning fluids, crop protection products, or the raw materials for everything from laptops and mobile phones to clothes and furniture. Across all, we have created an entire modern society with chemicals, and, as a result, constantly stretched the size of the world population we can feed, clothe and shelter. Yet, balancing all the gains from the modern chemistry around us against any negative environmental and human impact has been a rising concern, making for ever greater focus on testing and on risk assessment.

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Why chemical characterization is the best way to assess patient risk

Article | February 11, 2020

Everyone is very familiar with the phrase when buying a house: All that really matters are three things - location, location, and location. This same principle applies to extractables and leachables chemistry analysis – the three things that truly matter are identification, identification, and identification. The greatest growth in the past ten years in demonstrating the safety of medical devices and container closure systems for drugs has been using analytical chemistry to determine what chemicals can leach from the device and what the patient is exposed to during its intended use.

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How Chemical Companies Benefit from the Experience Economy

Article | February 10, 2020

To feel or experience from a business engagement started with customer experience mainly in the consumer products business. Today it has extended to even knowledge industries like the chemical industry where experiencing or feeling can be leveraged to include all stake holders from customers primarily to employees to supply chain people & suppliers and all else. With digital technologies this has become easier than before. The benefits from promoting the ‘feel’ or ‘experience’ emotion could be multifarious for the chemical industry as described in this article.

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Versalis SpA

Production and commercialization of polyethylene, base chemicals, polystyrene and elastomers. Based in Italy, has production sites in Italy, Germany, France, UK and Hungary. The European network is handled by Versalis International based in Brussels, Belgium.

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