Drug Safety/Pharmacovigilance Featured Articles
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Managing Clinical Risk For The Development Of Drugs And Devices
2/21/2013
Managing regulatory risk in an environment of increasing regulatory scrutiny is a critical success factor to consistently develop and launch new products efficiently. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of clinical development through a review of regulatory trends for a period of 18 months.
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Drug Safety In France & Underreporting Of AEs
2/12/2013
There is a lively controversy underway in France right now regarding drug safety. By Bart Cobert
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Challenges, Prechallenges, Dechallenges And Rechallenges
2/12/2013
This is an interesting topic for which several confusing points have arisen and which merits an in depth look. By Bart Cobert
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Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees
2/12/2013
This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients. By Bart Cobert
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FDA's December 2012 Guidance On IND And BA/BE Reporting - Part II
1/22/2013
Continuing with the review of the key points in FDA’s guidance. This is the second of three postings. By Bart Cobert
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FDA’s December 2012 Guidance On IND And BA/BE Reporting – Part I
1/9/2013
FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it. By Bart Cobert
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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
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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
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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
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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