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European Biopharmaceutical Review

Colours as Registered Trademarks

The pharmaceutical industry has been moving away from the traditional research-driven business model to one which is motivated by the marketing of major branded products. Compelled by the need to create bestseller products and then defend their sales post-patent expiry, pharmaceutical companies are increasingly using the power of branding to capture the hearts and minds of the public.

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By Sara Elwyn Jones, Associate at Taylor Wessing

Sara Elwyn Jones is an Associate in the intellectual property department of the London office of Taylor Wessing, an international law firm. After studying Law and French at Cardiff University and taking her Law Society finals at Nottingham, Sara trained for two years with the firm before qualifying into the intellectual property department two years ago. Sara specialises in all aspects of intellectual property including both contentious and non-contentious work.

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Sara Elwyn Jones
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News and Press Releases

Signant Health and ActiGraph simplify clinical trial activity and sleep monitoring for patients, sites, and sponsors with their new integration

Philadelphia, PA – November 14, 2019: Signant Health, formerly CRF Health and Bracket, is proud to announce that it has integrated its industry leading eCOA platform TrialMax®, with ActiGraph’s CentrePoint system. The integration, which includes ActiGraph’s FDA 510(k) cleared sensors, helps simplify the process of collecting and monitoring real-world activity, mobility, and sleep outcomes data for patients and researchers.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

23-26 March 2020, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 23 – 26 March 2020. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
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