Pharmacovigilance plays a crucial role in keeping patients safe by tracking adverse events linked to medicines. With regulatory requirements tightening worldwide, companies face growing pressure to deliver fast, accurate, and compliant translations for Individual Case Safety Reports (ICSRs).

At the 8th Annual Global Pharmacovigilance Summit, Cristobal Perez, Victoria Herrera, and Vladimiros Stafylidis from the Welocalize Life Sciences team tackled these challenges in the presentation, “Harmonizing Pharmacovigilance Translations: Ensuring Compliance and Quality with AI-Enhanced Solutions,” sharing insights on how combining AI technology with human expertise can streamline translation workflows.

Before we start, you can download the full presentation and notes here >>>

Managing the Complexity of ICSRs

ICSRs are critical documents in the pharmacovigilance process, providing vital information on adverse events. However, translating them presents significant challenges, especially for life sciences organizations that ensure patient safety and meet strict regulatory requirements.

ICSRs can take many forms, from structured documents to handwritten notes, images, or audio files, and they require rapid and precise translation to comply with agencies like the EMA, FDA, and MHRA.

Key challenges in pharmacovigilance translations for Life Sciences:

1. Diverse Formats and Data Types: ICSRs may be submitted as structured data, handwritten notes, or non-editable formats, complicating the preparation process for translation. Technologies capable of handling diverse content types are crucial for efficient workflows.
2. Regulatory Time Constraints: Regulatory bodies often mandate that ICSRs be translated within tight deadlines, sometimes as short as 24 hours. This urgency underscores the need for translation processes that balance speed with accuracy.
3. Complex Medical Terminology Across Multiple Languages: Life sciences companies deal with intricate medical language, drug names, and regulatory-specific phrases. Accurate translations are essential to avoid compliance risks and ensure patient safety.

Traditional manual translation methods, such as using Local Safety Officers (LSOs) to translate ICSRs, often struggle to meet the required speed and precision. While machine translation can assist with routine tasks, it may not be reliable enough for the specialized language used in life sciences, creating potential risks in regulatory submissions.

How AI-Enhanced Solutions Improve Pharmacovigilance Translations

Combining AI technology with human expertise presents a powerful approach to managing the complexities of pharmacovigilance translations in life sciences. This hybrid model is especially effective in addressing both regulatory demands and quality requirements:

1. Automated Content Preparation: AI tools streamline content intake and preparation, detecting the source language and converting non-editable formats into editable text using technologies such as Optical Character Recognition (OCR). This reduces the manual effort needed to prepare documents, allowing faster translation turnaround.
2. Automated Redaction and Anonymization for Compliance: AI-driven tools can automatically anonymize Personal Health Information (PHI) to comply with data protection regulations like GDPR. This ensures that sensitive data remains secure throughout the translation process.
3. Hybrid Translation Model with AI and Human Review: AI can manage the initial translation of standard phrases and terminology, while expert linguists review the output to ensure accuracy, especially for nuanced medical terminology and regulatory language. This approach aligns with the high-quality standards expected in life sciences.
4. Consistency Across Multilingual Content Using AI Tools: Leveraging translation memories and glossaries, AI tools maintain consistency in pharmacovigilance-specific terminology, such as adverse event descriptions and medical codes. This minimizes the risk of errors and ensures regulatory compliance across languages.

Navigating Regulatory Requirements with AI Solutions in Life Sciences

Meeting regulatory requirements is a critical concern in the life sciences industry, and AI-enhanced translation solutions can help navigate this complex landscape:

• Regulatory Compliance and Speed: Agencies such as the EMA and FDA demand rapid and accurate translations. AI-powered workflows facilitate compliance by enabling quick processing and human oversight to meet stringent quality standards.
• Data Security Protocols: Ensuring the confidentiality of PHI is a top priority in pharmacovigilance. AI-enhanced solutions help protect patient data by automating anonymization and adhering to encrypted data handling protocols.
• Ongoing Quality Assurance: AI can detect inconsistencies and flag them for review, continuously improving translation quality. This is vital for life sciences companies, where translation accuracy directly impacts patient safety and regulatory outcomes.

Future Trends Shaping Pharmacovigilance Translations in Life Sciences

The evolving landscape of pharmacovigilance will likely bring about stricter regulations and innovative applications of AI. Life sciences companies must prepare for these changes to remain compliant and competitive:

1. Increased Regulation of AI Applications: With the rise of AI in language services, regulatory bodies are expected to implement stricter standards for data security, transparency, and accuracy. Anticipating standards like the AI Act and ISO 42001 can help companies prepare for future compliance requirements.
2. Expanding AI Use Beyond Translations: AI is increasingly used for other pharmacovigilance tasks, such as case triage, automated narrative generation, and predictive analytics for detecting emerging safety issues. These advancements could transform pharmacovigilance processes across the industry.
3. Scalability for Diverse Life Sciences Companies: AI-driven translation solutions offer scalability, making high-quality workflows accessible to large pharmaceutical companies and smaller organizations. This allows for cost-effective operations without sacrificing compliance or quality.

Practical Strategies for Optimizing Pharmacovigilance Translations

For life sciences companies looking to optimize their pharmacovigilance translation workflows, consider these best practices:

1. Implement a Hybrid AI-Human Translation Approach: Use AI for routine translation tasks while relying on human reviewers for complex medical language and regulatory-specific terminology to maintain quality.
2. Utilize AI for Speed and Consistency: Automated tools can accelerate the translation process by handling repetitive tasks and ensuring consistency across multilingual content, which is crucial for meeting tight regulatory deadlines.
3. Focus on Data Security and Regulatory Compliance: Ensure your translation workflows incorporate data protection measures like automated PHI anonymization. Regular audits will help maintain compliance with evolving regulatory standards.
4. Stay Ahead of Regulatory Changes: Proactively adopt transparent and accountable AI practices to prepare for future regulations. Being adaptable to stricter AI standards will help ensure continued compliance.

Pharmacovigilance translations are critical in-patient safety, regulatory compliance, and operational efficiency within the life sciences industry. By embracing AI-enhanced solutions and combining them with expert human review, companies can better manage the complexities of pharmacovigilance translations, ensuring compliance with global regulatory bodies while optimizing workflows.