09/10/2013

MERRILL BRINK INTERNATIONAL
 
PHARMACOVIGILANCE:
Five Keys to Improving Language
Transparency for Optimized Reporting
 
Pharmacovigilance is gaining global attention as a multi- and cross-area discipline that deals with the incidence and frequency of adverse events related to pharmaceuticals and medical devices worldwide. The reporting of these events is critical to building a valid pharmacovigilance program that can effectively identify issues before they impact public health.
 
However, language can be a barrier in reporting. In many instances, adverse events and databases are reported in the local language. The adverse effect reports (AERs) must be translated from the local language to English, with care being taken to ensure that patient confidentiality is not breached at any point. Eventually, these reports are translated into multiple languages to meet various countries’ requirements. How prepared is your organization to address pharmacovigilance standards?
 
 
 
Does your organization have a formalized process for adverse event reporting?
 
 
Is your team trained in maintaining patient confidentiality?
 
 
Who is responsible for translating the AERs? Are the translators certified medical translation specialists?
 
 
What quality control protocols are in place to ensure that AER reporting is accurately captured and translated?
 
 
What financial and operational benefits can a language services provider offer?
 

Download Merrill Brink's white paper, “Pharmacovigilance: Five Keys to Improving Language Transparency for Optimized Reporting,” to learn more about global pharmacovigilance and how your organization can be optimally prepared for compliance.

DOWNLOAD WHITE PAPER
 
Merrill Brink International
One Merrill Circle
St. Paul, MN 55108
800.688.4400
translations@merrillcorp.com
Merrill Brink International Ltd.
Ballybrit Business Park
Galway, Ireland
353-91-393000
eurosales@merrillbrink.com
Merrill Brink International
3203, Lippo Tower One
89 Queensway, Admiralty
Hong Kong
+852 2110 2974
HKTrans@merrillbrink.com
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