Tag Archive: drug safety

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FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development – Safety

Bart Cobert reviews the FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development, and how it relates to safety.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

British journalist, biographer and statesman John Morley stated, “Evolution is not a force but a process.” In an effort to continuously improve the efficacy of drugs and health outcomes for patients, the healthcare industry gradually evolves to meet changing regulations, make the most of new technologies and communication channels, and[…]

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Bart’s Corner: Preparing and Coding Expedited Reports

In my thirty years in this business doing both medical and operational drug safety and pharmacovigilance, I’ve seen that just about every possible permutation of handling expedited reports has been used. In many cases, it does not matter how such reports are handled and most of the different methods work[…]

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FDA Draft Guidance on Rare Diseases

  FDA Draft Guidance: Rare Diseases: Common Issues in Drug Development Guidance for Industry August 2015 In August 2015, the FDA released this new guidance on rare diseases. Its aim is to aid sponsors and manufacturers in the development of drugs and products for rare diseases (defined more or less[…]

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Bart’s Corner: Late Expedited Reports to the FDA

In July, the Journal of the American Medical Association printed a Research Letter and an on-line editorial on pharmaceutical companies’ late expedited (15 day) reports to the FDA. The article (behind a paywall) can be found here. and the editorial here and here. The study is from the University of Minnesota. […]

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