|
 |
European Pharmaceutical Contractor
|
|
The Association of the British Pharmaceutical Industry (ABPI) has welcomed Government measures to bring the EU Clinical Trials Directive into national legislation and implement it by the 1st May 2004 deadline - despite the European Commission's delay in presenting a final Good Clinical Practice (GCP) Directive to member states for agreement. This is an important development, and is very encouraging for the UK-based pharmaceutical industry. Now among the first member states to comply with the Directive, the UK will appear even more attractive for companies conducting clinical trials, giving it a substantial competitive advantage.
But the ABPI's welcome for measures from the national Government is tempered by disappointment at delayed European legislation for paediatric medicines. The ABPI gave a qualified response to a draft proposal for a European Parliament and Council Regulation (EC) on medicinal products for paediatric use. However, there is general regret that this will further delay improvements to research and availability of medicines for children. The need for regulation on medicinal products for paediatric use within Europe is well-recognised, and it is frustrating that this issue is unlikely to be finalised for at least another 18 months. This can only serve to introduce further delay in the development of paediatric indications for medicines in Europe. |
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
Industry Events |
 |
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 >> |
|
 |
News and Press Releases |
 |
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 >> |
|
 |
