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European Pharmaceutical Contractor
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If an inspector wants to audit your facility tomorrow you will need to be able to prove that your staff have the ability and training to perform their job competently. This article highlights the regulatory pressure facing pharmaceutical companies and how management solutions can help.
Clearly, the financial rewards are great for those pharmaceutical companies that gain new insight into diseases and then develop wonder drugs that help arrest or treat them. But the regulatory requirements that govern the pharmaceutical industry are tight and growing tighter, and the need to manage compliance is crucial.
The impact of compliance is felt at every level - on drug substances and analytical research, on computer control systems and laboratory equipment, on Good Manufacturing Practice (GMP) operations and inspection techniques, and on documentation and people. And woe betide any organisation that fails to meet the standards. In the aftermath of a US$875 million settlement reached last Autumn between TAP Pharmaceutical Products and US federal prosecutors, pharmaceutical executives all over the world have been scrambling to understand how the bar has been raised for corporate compliance in their industry.
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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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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
More info >> |
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