Pharmacovigilance Solutions Framework
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Posted On :
Feb-25-2011
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Article Word Count :
375
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Pharmacovigilance is the process to ensure that company’s products remain in the market. In reality, a business faces the challenges of increasing complex and constantly changing worldwide regulations, requiring higher levels of inter-disciplinary expertise, together with demands to improve public safety.
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Pharmacovigilance is the process to ensure that company’s products remain in the market. In reality, a business faces the challenges of increasing complex and constantly changing worldwide regulations, requiring higher levels of inter-disciplinary expertise, together with demands to improve public safety. The pharmaceutical industry is in era in which it has reached the crossroads, facing the multiple challenges. The industry needs to overcome the challenges like the need to reduce timescales for new drug discovery, shrinking profit margins, supply chain pressures and changing regulatory requirements. The industry is in an extremely turbulent phase with tighter margins and lack of new drug offerings being typical characteristics of this sector.
Despite all these constraints, pharma companies continuously come out with new products. Surveillance of the safety of the product over its life on the market is very important in the first five years of a new drug, as the long term side effects are often unknown. These challenges have resulted in pharmacovigilance companies emerging as a thrust area in which Information Technology plays a major role. It helps in reducing the probability of drug recalls and increased safety to patients. Pharmacovigilance can be defined as the detection, assessment and prevention of adverse effects or any other possible drug related problems. This can include long term as well as short term side effects of medicines. There are quite a few areas of concern which have brought under the umbrella of pharmacovigilance like herbal medicines, traditional and complimentary medicines.
Pharmacovigilance solutions are gaining importance worldwide and recurring issues of adverse drug reactions. With a global increase in major drug withdrawals, the challenge of maximizing pharmacovigilance and drug safety and maintaining public confidence has become increasingly complex. The top challenges faced by pharmacovigilance industry are: complying with local and global pharmacovigilance requirements and evaluating available safety data and preparing an accurate safety database.
Thus, for pharmacovigilance solutions, one should meet the necessary obligations such as one needs the right IT infrastructure in place and adequate resources to manage and maintain the application and infrastructure. This requires documented procedures and skilled staff in order to stay informed and updated with the most recent regulations and to serve the end-customers in a cost-effective yet efficient manner.
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Article Source :
http://www.articleseen.com/Article_Pharmacovigilance Solutions Framework_53838.aspx
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Author Resource :
For more insights and further information about Contract clinical research, FDA Pharmcovigilance, Pharmacovigilance solutions,Drug safety associate, Pharmacovigilance in uk, Clinical research Professionals, Drug Safety consultant, Volume 9a pharmacovigilance, Clinical research uk and Pharmacovigilance services visit our site http://www.qsi.in
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Keywords :
Contract clinical research, FDA Pharmcovigilance, Pharmacovigilance solutions, Drug safety surveillance, Pharmacovigilance in,
Category :
Health and Fitness
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Health and Fitness
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