Lesson 4 - Regulatory Guidelines, Audits and Standards Flashcards
(30 cards)
What is VigiBase?
WHO’s global database for individual case safety reports (ICSRs), used to detect drug safety signals.
How does Vigilyze differ from VigiAccess?
Vigilyze: Tool for member countries to analyze VigiBase data; VigiAccess: Public portal for aggregated ADR statistics.
What is VigiFlow?
Web-based ICSR management system for national PV centers to collect, process, and share ADR reports.
Which ICH guidelines focus on pharmacovigilance?
E2A (expedited reporting), E2B (electronic reporting), E2C (periodic benefit-risk reports), E2E (PV planning).
What does CIOMS I address?
International reporting forms (links to ICH E2B for electronic ADR reporting).
What is the purpose of ICH E2E?
Guides pharmacovigilance planning, including risk management systems for post-marketing surveillance.
Which ICH guideline defines expedited reporting standards?
ICH E2A (Clinical Safety Data Management).
What is the Common Technical Document (CTD) under ICH M4?
Standardized format for regulatory submissions (quality, safety, efficacy data).
What is covered in CIOMS VIII?
Practical aspects of signal detection in pharmacovigilance.
Which CIOMS guideline addresses benefit-risk assessments?
CIOMS IV.
How do healthcare professionals report ADRs in Botswana?
Via web-based forms on BoMRA’s website or the Med Safety App.
Is ADR reporting mandatory in Botswana?
Yes, for physicians and pharmacists (serious ADRs).
What is BoMRA’s role?
Ensures drug safety, efficacy, and quality; oversees ADR collection and analysis.
Where are Botswana’s ADR reports shared?
WHO-Uppsala Monitoring Centre (VigiBase) and EMA.
Name a tool used for ADR reporting in Botswana.
Med Safety App (part of WEB-RADR project).
What is the purpose of a PV audit?
Ensure compliance with SOPs, regulatory requirements, and identify process improvements.
What is reviewed during a PV audit?
- Quality management systems
- Staff qualifications
- Database compliance
- Procedures for safety surveillance and risk mitigation
What are CAPAs in audit follow-up?
Corrective and Preventive Action Plans to address audit findings.
What happens during audit conduct?
Document review, interviews, facility tours, and closing meetings to present findings.
What is assessed in PV agreements with third-party vendors?
Contractual obligations for ADR reporting and safety data handling.
What is MedDRA?
Standardized medical terminology for regulatory activities (ICH M1).
Define Risk Management Plan (RMP).
Strategy to identify, assess, and minimize drug risks, required for new drugs.
What does CIOMS V cover?
Practical issues in pharmacovigilance, including stakeholder collaboration.
Which ICH guideline addresses pediatric drug development?
ICH E11
