Your Partner in Pharmacovigilance Compliance
Regulatory authorities such as the FDA, Health Canada, TGA, and EMA mandate pharmacovigilance (PV) or the collection, detection, assessment, monitoring, reporting, and prevention of adverse effects with drugs and medical devices. Together with our partners, AXSource supports our clients in ensuring compliance with post-marketing procedures.
AXSource supports the following pharmacovigilance services:
Compliance Documentation
- Pharmacovigilance system procedures and implementation of Standard Operating Procedures (SOPs).
- Preparation/review of technical and PV agreements.
- PV software system validation.
Safety Reporting to Regulatory Agencies
- Individual Case Safety Reports (ICSRs).
- Issue-Related Summary Reports (IRSRs).
- Annual summary reports in ICH and non-ICH formats, including PSURs, PBRERs, and PADERs.
Regulatory Inspection & Audit Support
- Self-inspection support.
- Compliance gap analysis audits.
- Preparation & hosting of GVP inspections.
- Corrective action and preventive actions.
- Good Pharmacovigilance Practices (GVP).
Take Proactive Steps Toward Compliance With AXSource’s Pharmacovigilance Expertise!
FAQs on Pharmacovigilance and Drug Safety
1. What is pharmacovigilance?
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
2. Why is pharmacovigilance important?
Pharmacovigilance is crucial for ensuring drug safety, protecting patient health, and maintaining regulatory compliance. It helps identify and mitigate risks associated with pharmaceutical products.
3. What services do pharmacovigilance consultants offer?
Pharmacovigilance consultants provide a range of services, including:
- Adverse Event Processing: Handling reports of adverse events and ensuring timely submission to regulatory authorities
- Signal Detection and Management: Identifying and evaluating potential safety signals from various data sources
- Risk Management: Developing and implementing Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
- Regulatory Intelligence: Keeping up-to-date with regulatory changes and ensuring compliance
- Literature Monitoring: Regularly reviewing scientific literature for new safety information
4. What is involved in pharmacovigilance audits?
Pharmacovigilance audits involve a comprehensive evaluation of PV systems to ensure compliance with global regulatory standards such as FDA, EMA, and ICH guidelines. Auditors assess processes, documentation, and systems to identify compliance gaps and recommend improvements.
5. How do pharmacovigilance solutions enhance drug safety?
Pharmacovigilance solutions streamline the management of safety data, improve the efficiency of adverse event reporting, and ensure compliance with regulatory requirements. These solutions often include advanced software tools for data analysis, reporting, and monitoring.
6. What are the benefits of pharmacovigilance consulting?
Benefits include:
- Expert Guidance: Access to specialized knowledge and experience in drug safety and regulatory compliance
- Improved Efficiency: Streamlined processes and systems for managing pharmacovigilance activities
- Regulatory Compliance: Ensuring adherence to regulatory requirements and avoiding penalties
- Enhanced Patient Safety: Proactive identification and mitigation of drug-related risks
7. How can pharmacovigilance consultants help with regulatory submissions?
Consultants assist with the preparation and submission of various regulatory documents, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Individual Case Safety Reports (ICSRs). They ensure that submissions are accurate, complete, and compliant with regulatory standards.
8. What is signal detection in pharmacovigilance?
Signal detection involves identifying potential safety issues from various data sources, such as adverse event reports, clinical trials, and scientific literature. It is a critical component of pharmacovigilance that helps detect new risks associated with pharmaceutical products.
