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European Pharmaceutical Contractor
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| Demand for qualified persons (QPs) is steadily on the rise since the EU implementation of the EU Clinical Trials Directive on 1st May, 2004. As Paul Thomas at Penn Pharmaceutical Services explains, this is an interesting and busy time for QPs across the industry
The EU Clinical Trials Directive implemented on 1st May, 2004 stated that a QP needs to have a personal knowledge and understanding of the manufacturing process, usually via site audit. For QP teams, this has resulted in a great deal of overseas travel, but also has been an excellent way to ensure that other clients can benefit from the experience and examples of best practice gained during these visits. However, there is a need to balance this extensive on-site role with pre- and post-audit support, presenting an interesting yet challenging situation.
The EU Clinical Trial Directive means that all medicines imported into the EU for use in clinical trials must be released by a QP and receive specialised handling, labelling, packaging and distribution. The UK is a relatively attractive route into the EU due to the proactive and communicative way that the UK MHRA has approached the introduction of the new legislation. At the same time as the introduction of the Clinical Trials Directive, the EU expanded by 10 member states. Access to this expanded population of clinical subjects, coupled with the added data security and patient safety brought by the new controls, further enhanced the EU as a good option for sponsors wishing to conduct clinical trials.
THE ROLE OF THE QP
The Code of Practice and Annex 16 to the EU guide to GMP clearly defines the role of the QP. The production processes for commercial products are fixed and validated and must therefore be applied rigidly. Any changes would need approval by the regulatory authority, either as a permanent variation or as a ‘single batch variation’ and would be assessed on data submitted. |
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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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