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Pharmaceutical Manufacturing and Packing Sourcer
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In March of this year, the European Committee for Standardisation (CEN) issued a draft standard, years in the making, intended to harmonise European Union countries' approach to child-resistant (CR) blister packaging for pharmaceutical products. The CEN's draft arrived just as the ink was drying on a newly revised standard proposed by the British Standards Institute (BSI), which was published barely three months earlier and now stands on the verge of becoming UK law.
Clearly, CR non-recloseable pharmaceutical packaging (including most blister packages) is the subject of considerable debate in the UK these days. While most interested parties share the opinion that some degree of child-resistance is necessary for blister packs in the UK, the provisions of any new standard, which would codify the requirements, have given rise to considerable debate.
Some parties are pushing for standards as strict as those in place in the United States, which are arguably the world's most stringent. Others point to significant hurdles that will make it difficult for the UK to adopt standards more rigorous than the ones that already exist. A protocol for testing the level of child-resistance in a package is still another point of debate.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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