TGA Seeks Feedback to Modernize Clinical Trial & Pharmacovigilance Australia’s Therapeutic Goods Administration (TGA) is revising its clinical trial and pharmacovigilance guidelines to align with global benchmarks—a move poised to reshape research and drug safety practices.
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Discover expert tips to avoid costly FDA submission mistakes in 2025. Learn how to ensure compliance, improve documentation, and accelerate product approval.
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EU GPSR (General Product Safety Regulation) The EU GPSR General Product Safety Regulation is a regulatory framework in the European Union that aims to ensure that products placed on the market are safe for consumers.
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The USFDA’s 2024 regulatory changes At Vigilare Biopharma, we understand the complexities and challenges that pharmaceutical companies face when navigating the ever-evolving regulatory landscape. The USFDA’s 2024 regulatory changes reflect a significant shift towards enhancing
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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.
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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
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The cosmetic facility that manufactures or processes a cosmetic product for distribution in the United States on December 29, 2022, must register each facility before July 1, 2024. Cosmetic facilities that first engage in the
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Pharmacovigilance is the science and practice of monitoring, evaluating, and managing the safety of medicinal products. It is essential to ensure that the benefits of a product outweigh its risks, and to identify and prevent
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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
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