Why technology is critical for pharmacovigilance harmonization

[Image courtesy of LeoWolfert via iStock]

Unified regulatory standards and pharmacovigilance harmonization are critical to enabling global pharmaceutical firms to operate more safely and efficiently. By normalizing the reporting of clinical data, stakeholders can minimize risks, improve market conditions, support early access to products, promote competition and efficiency, and reduce the unnecessary duplication of clinical testing.

Multiple regulatory agencies, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pan American Network for Drug Regulatory Harmonization, are looking for ways to achieve this. Through the use of technology, stakeholders can deploy tools such as artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) to improve safety monitoring and shift the industry from reactive to proacti…

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