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Is your clinical trial ready for ICH E6 (R3)? Discover the key areas to focus on, from risk-based quality management to digital transformation, and ensure compliance with the latest GCP guidelines.
Several Emerging trends are shaping the Pharmacovigilance and Regulatory Affairs domains in 2025 making their collaboration even more critical: 1. Integration of Artificial Intelligence (AI) and Machine Learning (ML) AI and ML are revolutionizing both PV and RA processes. AI-driven […]
The world of medicine is constantly evolving, and pharmacovigilance, the science of monitoring drug safety, is no exception. Traditional methods of tracking adverse drug reactions (ADRs) often rely on manual review and passive reporting, which can be slow and miss […]
Here are the top 10 trends in pharmaceutical industry innovations to embrace in 2024 1. Rise in Pharmacovigilance Market: The pharmacovigilance market is expected to grow at a CAGR of 13.6% from 2021 to 2028. Pharmacovigilance is the science of […]
At Vigilare Biopharma We strongly believe that medications play a crucial role in modern healthcare, but their benefits are intricately linked to their safety. A robust pharmacovigilance system is vital to ensure that medications are used safely and effectively. This […]
How CROs Can Support Pharmacovigilance and Regulatory Compliance? Pharmacovigilance is the process of monitoring, evaluating, and preventing adverse reactions or any other problems related to medicines. It is an essential part of drug development and post-marketing surveillance, as it ensures […]
DCTs are not a fad, but a trend that is transforming clinical research and patient care. By leveraging technology to make trials more accessible
involving patients directly in pharmacovigilance efforts can be a game-changer. Patient engagement offers unique insights, enhances reporting systems, and fosters a collaborative approach to drug safety.
As healthcare advances, new treatment modalities, personalized medicines, and innovative technologies are reshaping the landscape.
Pharmacovigilance guidelines serve as essential frameworks and standards that govern the practice of pharmacovigilance globally. These guidelines provide guidance and recommendations for various stakeholders involved in drug safety monitoring, including regulatory authorities, pharmaceutical companies, healthcare professionals, and researchers. Here is […]
