Regulatory authorities such as Health Canada and FDA mandate pharmacovigilance (PV) or the collection, detection, assessment, monitoring, reporting and prevention of adverse effects with drugs and medical devices.
AXSource supports the following pharmacovigilance services:
Pharmacovigilance System Design
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Pharmacovigilance system design and setup, including preparation of Standard Operating Procedures (SOPs)
Preparation/review of Technical and PV agreements Professional training |
Risk Management
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Development of Risk Management Plans (RMPs)
Preparation of product risk-benefit assessments and risk mitigation strategies |
Safety Reporting |
Individual Case Safety Reports (ICSRs) support, including medical assessment
Preparation of Issue-Related Summary Reports (IRSRs) |
Annual Summary Reports
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Preparation/ review of annual summary reports in ICH and non-ICH formats, including PSURs, PBRERs and PADERs |
Regulatory Inspection & Audit Support
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Self-inspections support
Compliance gap analysis audits Preparation/hosting of GVP inspections Preparation of corrective/preventive action responses |
Pharmacovigilance Training
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Professional training in clinical trial and post-market Serious Adverse Event (SAE) / medical device problem reporting and Good Pharmacovigilance Practices (GVP) |
Literature Searches
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Support with local and global literature searches and reviews |
AxSource also offers pre-market services in Clinical Affairs, including review and follow-up of SAEs and clinical trial management.