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When should I consider outsourcing my Pharmacovigilance or medical information program?
For companies with extensive resources and budget, outsourcing Pharmacovigilance and medical information services may not be necessary. Here are several factors to evaluate when making your decision. Outsourcing should be considered when: read more... -
What are the new Medical Devices Vigilance System guidelines?
The new guidelines released by MEDDEV, effective in June 2012, are intended to promote a uniform application and implementation of the Medical Device Vigilance System requirements included in the Medical Device Directives. What's new in these Medical Device Vigilance Guidelines? read more... -
What are the new Israeli adverse event and safety requirements issued in August of 2012 and how do they affect the pharmaceutical industry?
Below is a summary of the drug license holder’s requirements. For additional details, please see the official document in Hebrew or procedure summary in Hebrew. read more...