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Pharmacovigilance: The Regulatory Outlook

Pharmacovigilance Team

2012 saw the introduction of good pharmacovigilance practices (GVPs) in the European Union (EU) and since then, the industry has experienced a huge amount of change, including the introduction of the new EudraVigilance system in 2017. The new system, due to be fully implemented in 2019, is a European data processing network and management system designed to allow companies to report and evaluate suspected adverse reactions both during drug development and on an ongoing basis.

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Topics: Good Pharmacovigilance Practices, Eudravigilance, GVP Module VI, ICH E2B(R3), International Conference on Harmonisation (ICH), Regulatory Requirements, Good Clinical Practice (GCP), New Pharmacovigilance Legislation, Safety Database, European Medicines Agency

Risk-Based Monitoring and the Need for Programmers and Statisticians

Statistical Consultancy Team


The ICH E6 on Good Clinical Practice was updated on 9 November 2016, the first addendum for 20 years. Sections 5.0 on Risk and 5.18.3 on Extent and Nature of Monitoring in particular created an increased need for Risk-Based Monitoring (RBM) and Centralized Monitoring (CM). The details of how this may be covered and the increasing evolution of a risk in the industry have been noted. The required changes involved create a number of different team roles. These include opportunities for biostatisticians and statistical programmers - players who may not have been so directly involved in onsite monitoring, a more traditionally clinical domain.

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Topics: Risk Based Monitoring, International Conference on Harmonisation (ICH), ICHGCP E6, Centralized Monitoring, Fraud Detection, Source Data Verification (SDV), On-Site Monitoring, Visualization

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)

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