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ICH E2B(R3): Are You Ready For The New Update?

Pharmacovigilance Team


The International Conference on Harmonisation (ICH) has defined E2B as the international standard for transmitting medicine adverse event reports. The ICH E2B document includes message standards required for effective transmission of individual case safety reports (ICSR). Eventually, the need for the exchange of high volume of safety information world-wide efficiently and automatically has led to periodic revisions of the E2B document. Since 2001, when E2B(R2) was implemented, there have been many developments in regulatory reporting requirements and pharmacovigilance practices. Recently, the ICH E2B(R3) and M2 Expert Working Groups (EWGs) jointly developed an implementation guide on the standards adopted for electronic transmission of ICSRs. It includes new requirements that will require compliance by product manufacturers (and the organizations that assist them with reporting safety information).

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Topics: ICH E2B(R3), Pharmacovigilance, Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), Adverse Events (AEs), Patient Safety, Good Pharmacovigilance Practices, Safety Database, Standard Operating Procedures (SOP)

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: Pharmacovigilance, New Pharmacovigilance Legislation, Adverse Events (AEs), FDA, Black Triangle, European Medicines Agency, Good Pharmacovigilance Practices, Patient Narratives

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

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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