Tag Archive: drug safety

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.

UK and EMA Inspections Update 2019

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

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.

Brexit Update (again)

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

Confusions in Drug Safety & Pharmacovigilance

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

Language and Translations in PV

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

DMCs and SACs

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

Data Security, Protection and the US-EU Privacy Shield: Part 2

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

Exploring the role of the Medical Monitor in the clinical research process.

Data Security, Protection and the US-EU Privacy Shield: Part 1

Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.

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