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

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

ICHGCP E6 Addendum R2 - What do you need to know?

Gavin Boodoo



The ICH Guidelines for Good Clinical Practice (E6) has morphed into the international standard for clinical trial conduct since its inception twenty years ago. However, within that period, clinical research has changed dramatically and it is a credit to it’s authors that ICHGCP remains relevant today, with only one previous notable update seen in response to electronic data capture (EDC) technologies being widely utilized by the industry. 

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Topics: Good Clinical Practice (GCP), FDA, Remote Monitoring, Quality Assurance, Data Transparency, Additional Monitoring, Technology Trends, Risk Based Monitoring, Centralized Monitoring, ICHGCP E6

Remote Monitoring During Clinical Trials, a Risk Based Approach

Medical Writing Team

 

Within the last few decades the number and complexity of clinical trials has increased considerably, not only across the industry but within individual companies.  With this increase comes the enhanced pressure of effectively monitoring these trials.

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Topics: Regulatory Requirements, Clinical Trials, Good Clinical Practice (GCP), Clinical Data Storage, Case Report Form (CRF), Remote Monitoring, Adverse Events (AEs), Ethics, On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

Ben Goldacre Discusses Clinical Data Transparency [Video]

Statistical Consultancy Team

Dr Ben Goldacre, author of 'Bad Pharma' presented a keynote speech at the Clinical Data Live! symposium on clinical data transparency. 

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Electronic Medical Record (EMR), Adverse Events (AEs), Historical Data, European Medicines Agency, Clinical Trial Documentation, Clinical Documents, Ethics, Accessible Data, Data Transparency

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Statistical Consultancy Team

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

Quality Process Improvements and SOP Updates [Infographic]

Quality Assurance Team

This infographic explores Quality Process Improvement and Standard Operating Procedure (SOP) updates from a Clinical Research Organization (CRO) perspective. To confirm compliance to regulatory requirements, processes must be put into place - but how do we ensure our SOPs comply?

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), Quality Control, Quality Assurance, Quality Process Improvement, CRO Efficiency, Standard Operating Procedures (SOP)

How to Find Traceability Solutions For Your Outsourced Clinical Data

Michael Whitworth

The regulatory importance of knowing where your data are, reproducibility of results.  SI 2004/1031: Schedule 1, Part 2,10: “All clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.”

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), CRO Selection, Clinical Data Storage, Traceability

Quality Assurance in Clinical Trials – An Introduction to GCP

Quality Assurance Team

What is Good Clinical Practice?
One part of Quality Assurance in Clinical Trials is adhering to Good Clinical Practice (GCP). GCP is defined by EU Directive 2001/20/EC, article 1, clause 2 as:

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Topics: Good Clinical Practice (GCP), Quality Assurance

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