Pharmacovigilance & Risk Management

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

 

Pharmacovigilance system design and setup, including preparation of Standard Operating Procedures (SOPs)

Preparation/review of Technical and PV agreements

Professional training

 

Risk Management

 

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

 

Preparation/ review of annual summary reports in ICH and non-ICH formats, including PSURs, PBRERs and PADERs

 

Regulatory Inspection & Audit Support

 

Self-inspections support

Compliance gap analysis audits

Preparation/hosting of GVP inspections

Preparation of corrective/preventive action responses

 

Pharmacovigilance Training

 

Professional training in clinical trial and post-market Serious Adverse Event (SAE) / medical device problem reporting and Good Pharmacovigilance Practices (GVP)

 

Literature Searches

 

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.