Tag Archive: drug safety

Getting Started in Pharmacovigilance – Part 2

In Part 1 we talked about concepts and starting the preparation for job hunting.  Here are the next steps.

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Getting Started in Pharmacovigilance – Part 1

Interested in a career in Pharmacovigilance?

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FDA Guidance on Biosimilar Labeling

Bart Cobert reviews the newly published FDA draft guidance for industry on Labeling for Biosimilar Products.

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Animal Health 101: Key Components of a Veterinary PV Program

As in the human medical sciences field, the world of veterinary PV is constantly evolving. Explore the 4 main components of an animal health PV program.

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The French Phase I Trial Disaster

Bart Cobert discusses the lessons learned from the recent Phase I trial disaster in France.

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FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development – Safety

Bart Cobert reviews the FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development, and how it relates to safety.

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PV Inspections of Contract Service Providers

An update on inspections by governments and health authorities of CROs and other pharma service providers.

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EudraVigilance Stakeholder Change Management Plan

EMA Changes to EudraVigilance (EV), ICSR reporting and SUSAR reporting

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Bart’s Corner: Coding MedDRA and ICD-10

Comparing Coding MedDRA and ICD-10

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Bart’s Corner: Danish HA Guide on PV

In June, the Danish Health and Medicines Authority (DHMA), issued its Guide to Individual Case Safety Reporting. This is a 60 plus page “best practice” (their words) document describing the process for submitting individual case safety reports (ICSRs) to them using the E2B standard to “complement current EU legislation and[…]

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