Hospital ADR Reporting Services (Vanessa’s Law)
We support reporting for pharmaceuticals, biologics, medical devices, DINs, NPNs, and more, aligning with Health Canada guidelines for electronic submissions via the Canada Vigilance Program.
COMPÉTENCE
Compliance Support Tailored for Canadian Hospitals
We understand the unique pressures hospitals face under Vanessa's Law, the Protecting Canadians from Unsafe Drugs Act, which mandates reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to Health Canada. Our boutique approach starts with listening to your institution's specific needs, then crafting customized solutions to ensure seamless compliance, from documentation to submission, helping mid-sized healthcare facilities navigate these requirements with reliability, speed, and transparency.
Enacted to enhance post-market drug safety, Vanessa's Law requires hospitals to report serious ADRs (those causing death, life-threatening conditions, hospitalization, disability, congenital abnormalities, or requiring intervention) and MDIs within 30 calendar days of first documentation in patient records.
NOS SOLUTIONS
Core Services for ADR and MDI Reporting
Our services focus on simplifying mandatory reporting, adaptable to your hospital's workflow while exceeding Health Canada standards.
We provide end-to-end support for identifying, documenting, and reporting serious ADRs, ensuring all required details like patient demographics, reaction description, drug details, and outcomes are captured accurately and submitted within the 30-day window.
Key Components
- Bilingual case intake and assessment in English and French
- Integration with hospital records for proactive identification
- Narrative writing and MedDRA coding for compliant reports
- Electronic submission to Health Canada with confirmation tracking
Leverage our technology to streamline Vanessa's Law compliance, integrated with your systems for minimal disruption.
AI-Enabled Screening and Monitoring
Our automated tool scans hospital databases and vigilance sources for potential ADRs/MDIs, using validated keywords and machine-translation to flag reportable events early, ensuring nothing falls through the cracks.
Validated Reporting Database Access
Gain customized, secure access to our database for tracking reports, deadlines, and KPIs, providing full transparency and audit-ready records compliant with Health Canada requirements.
Drug safety is everyone's responsibility we offer GVP-compliant programs tailored for hospital staff, covering ADR/MDI identification, reporting protocols, and integration with PV. Bilingual sessions include onboarding for new hires and annual refreshers to build confidence and reduce underreporting.
Training Highlights
- Scenario-based workshops on serious ADR recognition
- Guidance on electronic vs. paper reporting options
- Focus on hospital-specific challenges like ED visits
Prenez un RDV téléphonique
Réservez dès aujourd'hui un appel de découverte avec un associé principal de Zenith PV pour discuter de vos besoins, découvrir les lacunes et démarrer votre parcours de conformité.
Connecting Vanessa's Law to PV Support
Our services integrate hospital reporting with pharmacovigilance, regulatory affairs, and quality assurance, ensuring ADRs/MDIs feed into aggregate reports, audits, and submissions. Rooted in trust and ownership, we offer direct senior partner access no bait-and-switch for transparent, referral-worthy partnerships that enhance safety and compliance.
Reduces non-compliance risks through early detection
Supports hospitals with nimble, bilingual expertise
Builds lasting confidence in your reporting processes
English 
French