Drug Safety/Pharmacovigilance Featured Articles

61. Organizations That Deal With Pharmacovigilance And Drug Safety – Part 2 Training & Education 1/8/2013

    In an earlier post, we talked about organizations that deal with drug safety.  In this post, we will talk about organizations that do training and education in drug safety and pharmacovigilance. By Bart Cobert

62. FDA's SOP For FDA's PV Inspectors 1/8/2013

    In December 15, 2012 FDA issued its updated Chapter 53 on Postmarketing  Adverse Drug Experience (PADE) Reporting Instructions. This is part of FDA’s Compliance Program Guidance Manual but is, in reality, more or less an SOP for FDA’s inspectors. By Bart Cobert

63. Organizations That Deal With Pharmacovigilance And Drug Safety – Part 1 12/21/2012

    In an earlier post, we talked about the Uppsala Monitoring Centre in Sweden. This is the major organization (outside of governments) that deals almost purely with drug safety. By Bart Cobert

64. Source Documents And Data Retention In Drug Safety 12/20/2012

    In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. By Bart Cobert

65. The Uppsala Monitoring Centre (UMC) 12/20/2012

    There is an organization that has done basic, pioneering work in drug safety and pharmacovigilance and that today continues to play a unique role in this field. By Bart Cobert

66. Pharmacovigilance And Pregnancy 12/20/2012

    Obviously, the safety of drugs in pregnant and breast-feeding women, the embryo/fetus and, less directly, the male partner are of paramount importance. By Bart Cobert

67. Drug Induced Liver Injury (DILI) 12/20/2012

    The liver is the first stop on the path a drug takes after oral ingestion. From the liver’s “point of view”, drugs are like other exogenous agents and are handled by the liver for excretion. By Bart Cobert

68. Expert Insight Into ePRO Industry Trends 6/7/2012

    As technologically savvy as we think we have become, there are still plenty of studies being conducted via pen and paper. By Rob Wright

69. What Do Consultants Look For When Advising Drug Development Companies On CRO Selection? 5/16/2012

    L.E.K., founded in 1983, is a global strategy consulting firm with offices across Europe, the Americas, and Asia-Pacific. One of its more than 900 employees, Jonathan Kfoury, functions as the VP of L.E.K.’s Boston office, with a focus on R&D, partnership, and commercialization strategy development for biopharmaceutical and medical technology companies. By Rob Wright

70. Mobile Devices Pave The Path For Clinical Research Evolution 5/11/2012

    Clinical trial sponsors looking to stay at the forefront of efficiency and accuracy should consider whether they are making the best use of the growing trend of access to clinical data on mobile devices. From the secure sharing of electronic patient reported outcome (ePRO) data, to creating more flexible clinical data management, mobile technology has the potential to improve processes across the clinical research process. By Rick Morrison, CEO, Comprehend Systems