Tag Archive: drug safety

Reporting and Not Reporting Data

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 addresses the use of marijuana for medical purposes and the implications for Drug Safety.

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Signal Detection and Signal Management

Dr. W. Mark Riddle, M.D explores signal detection and signal management in Pharmacovigilance.

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Guide to Causality Assessment

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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UK and EMA Inspections Update 2019

Bart Cobert reviews the changes and updates happening with UK and EMA inspections.

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Safety Reporting: Why We Do What We Do

We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.

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Brexit Update (again)

An update on the status of Brexit and the EMA move to Amsterdam.

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Confusions in Drug Safety & Pharmacovigilance

Bart Cobert addresses confusing areas in Drug Safety and Pharmacovigilance including Brexit, basic terminology, date formatting and others.

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Language and Translations in PV

Pharmacovigilance expert Bart Cobert examines the issues associated with language translation in PV and drug safety.

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When is a Signal Not a Signal?

When is a Signal Not a Signal?

Bart Cobert highlights the intricacies of signal detection. Including those instances in which a signal may not be a signal.

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