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Clinical Trials & REMS in the Time of Corona: FDA & MHRA Advice and Guidance
Bart Cobert / Apr 09, 2020
Pharmacovigilance expert Bart Cobert discusses the FDA and MHRA guidance for non-Corona related clinical trials.
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Does Rapid FDA Approval Produce Drug Safety Issues?
Bart Cobert / Mar 16, 2020
Bart Cobert gives his pharmacovigilance point of view on a recent paper on FDA approval timelines and drug safety issues.
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Pharmacovigilance 2030
Bart Cobert / Dec 11, 2019
This is an interesting article looking at what PV will be in the year 2030.
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Vaping – A Serious Safety Signal
Bart Cobert / Oct 07, 2019
Bart Cobert discusses the major safety issue in the US on e-cigarettes and vaping.
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Importing Canadian Drugs to the US
Bart Cobert / Aug 29, 2019
Bart Cobert covers several issues involved in setting up the proposed "Safe Importation Plan" which aims to allow US consumers to get safe and cheaper drugs.
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No-No’s in Drug Safety
Bart Cobert / Aug 13, 2019
An overview covering a number of things to avoid doing when it comes to drug safety.
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Different Regulatory Actions from Different Agencies
Bart Cobert / Jun 27, 2019
Bart Cobert explores the potential reasons for the differing regulatory actions from the different agencies.
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Reporting and Not Reporting Data
Bart Cobert / Jun 03, 2019
Bart Cobert discusses the importance of clinical safety reporting. Not only is this a legal responsibility but also an ethical one.
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Medical Marijuana and Drug Safety
Bart Cobert / May 07, 2019
Bart Cobert addresses the use of marijuana for medical purposes and the implications for Drug Safety.
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Guide to Causality Assessment
Bart Cobert / Mar 20, 2019
What information should be examined in the study and work up of ADRs to determine whether the reaction is likely due to the drug or not.
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