Why Cloudbyz PV Database is your best bet for navigating evolving PV regulations across the UK and the US.

The pharmacovigilance (PV) landscape is undergoing rapid transformation globally, driven by changing regulatory requirements, advancements in technology, and the increasing complexity of clinical research. Regulatory bodies such as the MHRA in the UK and the FDA in the US are introducing new frameworks and initiatives to enhance drug safety and improve compliance processes. For MAHs managing PV operations, staying ahead of these changes requires robust and adaptable systems that can streamline workflows, integrate new data sources, and ensure compliance with evolving standards.

The Windsor Framework, effective from 1st January, 2025, has brought significant updates to the regulation of medicines in the UK, particularly Northern Ireland. It replaces the Northern Ireland Protocol and introduces new pharmacovigilance requirements:

• Dual Reporting Requirements: Medicines marketed in Northern Ireland must comply with both EU and UK pharmacovigilance reporting requirements, using EudraVigilance for the EU and the MHRA Yellow Card Scheme for the UK.
• UK-Wide Licensing Integration: Medicines in Northern Ireland are now licensed under a UK-wide framework, simplifying some processes but requiring updated compliance across jurisdictions.
• Product Categorization: Centrally authorized EMA medicines follow EU pharmacovigilance rules, while other medicines adhere to MHRA standards with local reporting for Northern Ireland.
• Adverse Event Monitoring: Harmonized data submission and alignment with Good Pharmacovigilance Practices (GVP) are mandatory for dual compliance.
• PSMF Accessibility: The Pharmacovigilance System Master File must be accessible to both EMA and MHRA inspectors, with potential location updates for dual jurisdiction.
• Supply Chain Monitoring: Robust safety monitoring is required for investigational and approved products moving between Great Britain and Northern Ireland.
• Streamlined Inspections: Inspection readiness requirements are evolving to accommodate dual compliance obligations, focusing on aligned safety practices.

These changes highlight the importance of having a PV system capable of handling jurisdiction-specific workflows and dual reporting obligations seamlessly.

The FDA has taken significant steps to integrate Real-World Evidence (RWE) into pharmacovigilance frameworks, aiming to enhance drug safety monitoring by leveraging real-world data sources like electronic health records and patient registries. Key updates include:

• Expanded Data Sources: RWE is now used to supplement traditional clinical trial data, providing a more comprehensive understanding of drug safety.

• Guidance Updates: New FDA guidelines emphasize incorporating RWE into adverse event monitoring and post-market surveillance.

• Advanced Signal Detection: The use of RWE enables more effective identification of safety signals across diverse populations.

Organizations must adapt their PV systems to integrate and analyze RWE effectively, ensuring compliance with these updated FDA requirements.

Cloudbyz’s Safety & PV database is uniquely positioned to address the challenges posed by the rapidly evolving PV landscape. Here’s why Cloudbyz stands out:

• Flexibility: Cloudbyz’s solutions are built on a configurable, low-code platform that can be tailored to meet jurisdiction-specific workflows, including dual compliance requirements under the Windsor Framework and RWE integration for FDA submissions.

• Fast Setup Time: The platform’s modular design ensures quick implementation, reducing time-to-value for organizations looking to modernize their PV operations.

• Easy Integration with Open APIs: Seamlessly integrate with existing systems, real-world data sources like electronic health records (EHRs), patient registries, etc.

• Scalability and Compliance: Built on Salesforce’s scalable infrastructure, Cloudbyz ensures compliance with global standards such as FDA 21 CFR Part 11, HIPAA, GDPR, and GAMP5.

By leveraging Cloudbyz, organizations can future-proof their pharmacovigilance operations, ensuring compliance, efficiency, and improved drug safety outcomes in a rapidly changing regulatory environment.