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Pharmacovigilance Team

Pharmacovigilance Team

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The History of Pharmacovigilance Infographic

Pharmacovigilance Team
Where and when did Pharmacovigilance begin? Medical remedies have been recognized by mankind for thousands of years, and so have their potential dangers, side effects, and benefits. During the 20th century there were some serious adverse events associated with medical products and drugs that resulted in pressure on governments, businesses to produce legalization and guidance, as well as the evolution of regulatory bodies to protect the safety of patients. This infographic identifies those significant milestones across the 20th century and into the modern era.
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Topics: FDA, Adverse Events (AEs), Pharmacovigilance, New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency, Patient Narratives, Black Triangle

Is Lack of Data the Biggest Challenge for Early Phase Pharmacovigilance?

Pharmacovigilance Team

We recently hosted a webinar on the challenges of Pharmacovigilance in early phase clinical trials. During the registration process we had the chance to survey members of the industry, 70% of the respondents were from pharmaceutical, biotechnology or medical device companies. We wanted to present the data from the 150 respondents in this blog.

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Topics: Regulatory Requirements, FDA, Phase I Studies, Adverse Events (AEs), Pharmacovigilance, Serious Adverse Events (SAEs), Clinical Trial Phases, Oncology

How will the change in European Device Regulations affect vigilance practices?

Pharmacovigilance Team

On 22 October 2013 the European Parliament agreed to new proposals for regulation on Medical Devices and in vitro diagnostic medical devices. Outdated legislation and high profile scandals have made changes a necessity. This is despite disagreements between legislators and industry over the content of the new legislation. But how will this impact vigilance practices and will it stop medical device scandals from ever happening again?

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Pharmacovigilance - The Black Triangle and Additional Monitoring

Pharmacovigilance Team

 

In July 2012 the new Pharmacovigilance legislation came into effect with a focus on robust systems for public health that encourage efficiency and transparency. The EMA Executive Director Guido Rasi explained that:

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Topics: Pharmacovigilance, New Pharmacovigilance Legislation, European Medicines Agency, Additional Monitoring, Black Triangle

Are you ready for the New Pharmacovigilance Legislation?

Pharmacovigilance Team

As the European Medicines Agency finalizes the first set of Good Pharmacovigilance Practices are you ready for the Transition to the New PV Legislation?

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Topics: Pharmacovigilance, New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency

Compliant with the new Eudravigilance Medicinal Product Dictionary?

Pharmacovigilance Team

With just over a week to go before the Article 57(2) requirements for population of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) become mandatory, the European Medicines Agency (EMA) has today published an updated version of the ‘eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Frequently Asked Questions & Answers (FAQs)’ document.

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Topics: Pharmacovigilance, Eudravigilance, Medicinal Product Dictionary (XEVMPD), New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency

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