|
 |
European Pharmaceutical Contractor
|
The greatest challenge of the 21st Century will be the introduction of integrated e-business processes into the daily routine of pharmacovigilance for all aspects of information creation, analysis and communication. The electronic communication is, however, only the externally visible part of information handling. The better the processes that precede or follow the communication are integrated and supported by intelligent data handling or production techniques, the higher the benefit from e-business.
In pharmacovigilance the task of collection, documentation distribution and regulatory reporting of case reports on adverse experiences related to drugs by pharmaceutical companies and regulatory authorities is predominant. Though this activity is only the first step in a decision-making process to determine the risk profile and ultimately the risk benefit ratio of a drug, it devours vast resources and is in the focus of most regulatory compliance measures. Individual case safety reports (ICSR) are exchanged through a tight and highly regulated network of mutual obligations. The same case safety report will therefore appear in multiple institutions and will be entered into a database.
Every day thousands of case safety reports (adverse event reports) are distributed throughout the world. The FDA alone received 276,000 case reports in 1999. There is reason to believe that this transaction is probably the most frequent communication in the pharmaceutical world. Until now, case safety reporting relied largely on paper-based formats, such as the CIOMS, MedWatch, Yellow Card, BfArM and others.
|
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 |
 |
“PACK DIFFERENT” with EMBALLAGE 2008
“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
More info >> |
|
 |
