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European Pharmaceutical Contractor
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| The latest EMA Guidelines on Environmental Risk Assessment may have slipped past your attention; their effects on pharmaceuticals in the environment (PiE), however, will do anything but, cautions David Cocker of Ecotrac NV
After seven years’ evaluation, the EMEA last month published guidelines on pharmaceuticals in the environment. As of December 2006, a ‘robust’ environmental risk assessment has to be submitted with all new marketing authorisation applications. Why did this guidance take so long to develop? And what’s the long-term impact for pharma? For some time, most EU companies have been required to substantiate product safety (human and environmental) by in-depth risk assessment. So why is pharma only being called on now to join the party? Pharma is one of the best industries in the world at evaluating the risks of their products to man, but how do their green credentials line up against other industries when assessing risk to the environment?
SOCIETY AND SCIENTIFIC COMPROMISE
While society wishes for increased eco-vigilance, it also wants to reduce excessive use of animal testing. Creation of this EMA policy did not stem from knowledgeable risk assessments, rather from the lack of it. The question is this: ‘can industry and the scientific community fill the data vacuum that society has been lead to believe is missing?’ These new policies not only place increasing responsibility on manufacturers to demonstrate eco-safety, but also exert additional demands on scientific knowledge to sustain plausible regulatory judgements. |
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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 Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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