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| home > ebr > summer 2003 > cold chain: risk, regulatory compliance and operational performance |
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 PUBLICATIONS |
European BioPharmaceutical Review
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Risk assessment is, at best, an honest attempt to find a rational basis for decisions by analysing the available scientific evidence. In theory it is still an attractive ideal - to make rational decisions based on scientific evidence - because in principle it should allow diverse parties to agree on what needs to be done. However, years of actual practice have badly tarnished the ideal of risk assessment.
In the first place, the necessary data are not always available, even today. In the second place, the traditional toxicological assumptions do not always hold up under scrutiny. There is no agreement on which tests to use to determine whether someone's immune system has been damaged. There is no agreement on which tests should be used to assess damage to the nervous system. There is no agreement - and there may never be - on ways to test for genetic damage.
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By Sean Flanagan, the Commercial Director at Kryotrans Ltd, and Adrian Shaw, Partner at Ikon Associates
Sean Flanagan is the Commercial Director at Kryotrans Ltd. A qualified accountant, Sean has considerable financial and operational experience with a range of large and small organisations, such as United Technologies Corporation and PROTX Ltd, an Internet start-up company.
He is one of three directors at Kryotrans Ltd. He is responsible for marketing, finance, sales and administration and has also developed a number of strategic partnering relationships.
Adrian Shaw is a Partner at Ikon Associates, Marketing Consultants. Having trained in accountancy with Coopers and Lybrand, Adrian has spent the last 15 years working in the PR and marketing services world.
He has previously worked as a Director for Gavin Anderson & Co, a PR consultancy, before moving on to Burston Marsteller, where he was a Managing Director responsible for financial and corporate communications work across Europe. He now runs his own corporate brand and marketing services consultancy.
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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...
More info >> |
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