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| home > epc > spring 2003 > data exclusivity under review - striking the balance between originator and generic medicines |
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European Pharmaceutical Contractor
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On 18th July 2001, the European Commission presented details of its proposal for a comprehensive reform of EC pharmaceutical legislation (1). This reform will affect the mutual recognition, or decentralised, procedure as well as the centralised procedure laid down in Regulation (EC) No. 2309/93, and will apply to both medicinal products for human use and veterinary medicinal products (2). The main objectives of the proposal are:
To ensure a high level of public health protection for the European citizen, in particular by allowing rapid access to innovative and safe products and by tight market surveillance, based on reinforced procedures of control and pharmacovigilance
To further complete the internal market in pharmaceuticals and to establish a regulatory framework favourable to the competitiveness of European pharmaceutical industry, while taking into account the stakes of globalisation
To meet the challenges of an enlargement of the European Union
To rationalise and simplify, as far as possible, the current system and to improve its global coherence, its visibility and the transparency of its procedures
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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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MipTec, October 14 – 16, 2008, Switzerland
MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com
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