The New EMA Protect ADR Database

Bart Cobert / Feb 20, 2013

On February 18, 2013 the EMA released a new Adverse Drug Reaction (ADR) database. See: https://www.imi-protect.eu/methodsRep.shtml It is called the Protect Database and was developed by the EMA and some[…]

MHRA’s Compliance Report

Bart Cobert / Feb 13, 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[…]

Challenges, Prechallenges, Dechallenges and Rechallenges

Bart Cobert / Feb 06, 2013

This is an interesting topic for which several confusing points have arisen and which merits an in depth look. These concepts are frequently used in the discussion of causality and[…]

Breaking the Blind in Clinical Trials & Reporting to Health Authorities, Investigators & IRBs/Ethics Committees

Bart Cobert / Jan 30, 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[…]

Drug Safety in France & Underreporting of AEs

Bart Cobert / Jan 23, 2013

There is a lively controversy underway in France right now regarding drug safety. To a certain degree this parallels what happened in the United States about 10 years ago when[…]

FDA’s December 2012 Guidance on IND and BA/BE Reporting – Part 3

Bart Cobert / Jan 16, 2013

FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it. See: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf and www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332846.pdf respectively. Continuing with the review of[…]

FDA’s December 2012 Guidance on IND and BA/BE Reporting – Part 2

Bart Cobert / Jan 09, 2013

FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it. See: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf and www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332846.pdf respectively. Continuing with the review of[…]

FDA’s December 2012 Guidance on IND and BA/BE Reporting – Part I

Bart Cobert / Jan 02, 2013

FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it. See: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf and www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332846.pdf respectively. The Q&A is short and[…]

FDA’s SOP for FDA’s PV Inspectors

Bart Cobert / Dec 26, 2012

On 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[…]

Organizations that Deal with Pharmacovigilance and Drug Safety – Part 2 Training & Education

Bart Cobert / Dec 19, 2012

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[…]