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Pharmaceutical Manufacturing and Packing Sourcer
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In recent years claims that non-reclosable flexible packaging for pharmaceutical solid dose products - in particular blisters - are not child safe have become more frequent. The Child Safety Packaging Group in the UK has been lobbying for a relative standard since 1995 and increased their activities following the lethal ingestion of 44 tablets containing ferrous-sulphate by a three year old boy - tablets that had allegedly been packed in blisters, although no evidence to prove this was produced.
Following a public debate it was decided that the UK would introduce a British standard and not wait for the Centre Européen de Normalisation (CEN) to present a European standard so that the MCA could revise its legislation.
The idea of child-resistant packaging was first introduced in the US by the Code of Federal Regulation in 1974. While the importance and benefits of legislation are widely accepted and regulation regarding potentially harmful household product is covered by EU Directives, only four member states have legislation covering pharmaceuticals. Germany introduced DIN 55559 in 1980 with the Netherlands following closely behind. In Italy testing does not allow the involvement of children but accepts child-resistant packaging as soon as it has been recognised as being child-resistant in another EU member state.
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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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News and Press Releases |
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MipTec, October 14 – 16, 2008, Switzerland
MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com
More info >> |
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