Drug Safety/Pharmacovigilance Featured Articles
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Global Call Centers For Life Sciences Organizations
5/7/2013
When we think of call centers, images of the past tend to come to mind. We are reminded of the switchboard ladies in Mad Men, or outsourced client service centers where operators may not have the right linguistic or industry-specific knowledge to fully assist the customer. By Michael Smyth, General Manager, TransPerfect Life Sciences Solutions
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Pharmacovigilance: Recent Developments & Future Perspectives
4/17/2013
The development of new and effective medicinal products makes a positive contribution to the health and well-being of individuals. However, there is a need to improve pharmacovigilance (PV) systems to more effectively monitor and take action on safety issues associated with medicines to enhance their contribution to public health. By Dr. N. Arulmozhi, MPT, PGDCR & PV, Drug Safety Associate
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Pharmacovigilance Trends: Getting To Know The DSUR
4/15/2013
In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. By Malarkodi S. Moorthy, M.Sc., M.Phil., Medical Writer
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The High Cost of Clinical Research – Who’s To Blame And What Can Be Done?
4/8/2013
The cost of new drug discovery has skyrocketed in recent years, and is something that should have everyone in the drug discovery industry concerned. Sergei Varshavsky, M.D., Ph.D., and senior VP of global strategy for contract research firm Synergy Research Group (SynRG), notes it was not always this way. Some of the greatest medicinal discoveries in the history of mankind were inexpensive to develop and test. “There was the discovery of the smallpox vaccine in 1796, ether anesthesia in 1846, and insulin and penicillin in the early 20th century,” he says. “None of them cost much. In fact, the patent for insulin was sold to the University of Toronto for a half-dollar. Despite the low cost, these drugs have saved billions of lives.” Unfortunately today’s medical community is no longer able to accomplish similar feats for such a low cost.
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MHRA’s Summary Of PV Systems (SPS) Document
3/26/2013
As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. By Bart Cobert
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MHRA’s Compliance Report
3/26/2013
On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert
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EU Module 15 Safety Communications
3/26/2013
On January 24, 2013 the EMA’s latest Good PV Practices Module 15 on Safety Communications came into force. By Bart Cobert
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The New EMA Protect ADR Database
3/26/2013
On February 18, 2013 the EMA released a new Adverse Drug Reaction (ADR) database. By Bart Cobert
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Former Acorda Chief Medical Officer Discusses Benefits And Pitfalls Of Outsourcing
3/18/2013
Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.
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The Role Of Language Translation In Clinical Trials
2/27/2013
As clinical trials become an increasingly global affair, clinical translators will become a key element in the trial implementation.