Tag Archive: Pharmacovigilance

EMA GPVP Module V – Risk Management: Draft Revision 2

In February 2016 the EMA released a draft of the revisions for the new version of Module V on Risk Management.

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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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IND Safety Reporting

FDA’s Safety Assessment for IND Safety Reporting Draft Guidance

Bart Cobert examine's the FDA's latest guidance on Safety Assessment for IND Safety Reporting

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FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development – Safety

Bart Cobert reviews the FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development, and how it relates to safety.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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SAE Reporting for Outsourcing Facilities (Compounders)

Bart Cobert reviews the FDA guidance on AE Reporting for Outsourcing Facilities (Compounders)

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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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