Tag: Drug safety

Pharmacovigilance 2026: The Future of Regulatory Drug Safety

Pharmacovigilance 2026 is set to be a definitive platform for patient safety, featuring strengthened and automated vigilance systems. The future of Pharmacovigilance is poised for a transformative shift, driven by new avenues such as automation

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Deep Dive: Best Practices for Compiling a Robust Pharmacovigilance System Master File (PSMF)

Deep Dive: Best Practices for Compiling a Robust Pharmacovigilance System Master File (PSMF)

Introduction In today’s highly regulated pharmaceutical environment, a company’s pharmacovigilance system defines its credibility, transparency, and commitment to patient safety. At the heart of this system lies the Pharmacovigilance System Master File (PSMF) — a

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Deep-Dive-Best-Practices-for-Robust-Signal-Detection-and-Management

Deep Dive: Best Practices for Robust Signal Detection and Management in Real-World Data

In an era where real-world data (RWD) is reshaping pharmacovigilance, the ability to detect and manage safety signals effectively has become a cornerstone of regulatory compliance and patient protection. With data flowing from electronic health

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Mastering Post-Approval Changes: Transform Regulatory Hurdles into a Competitive Advantage

Mastering Post-Approval Changes: Transform Regulatory Hurdles into a Competitive Advantage

The Evolving Pharma Landscape: Innovation Demands AgilityThe pharmaceutical industry is a dynamic ecosystem where innovation never sleeps. From advancements in manufacturing technologies to shifts in formulation strategies, post-approval changes are inevitable. Yet, every modification—whether to

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How EU General Product Safety Regulation (GPSR) can impact your Pharma business?

How EU GPSR General Product Safety Regulation can impact your Pharma business?

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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Navigating the Complexities of Global Regulatory Submissions

Each country has unique regulations and documentation requirements, making it essential to develop a comprehensive strategy to ensure compliance across various regions. Here are some key strategies and tools to streamline the global regulatory submissions

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Hyderabad Global Capability Centre’s as Pharma Hub

Hyderabad, the capital of Telangana, has emerged as a prominent pharma hub in India, attracting global pharmaceutical companies and investors. Its strategic location, coupled with a favourable business environment, has made it a preferred destination

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Good Pharmacovigilance Practices by EU

Understanding Good Pharmacovigilance Practices (GVP): Ensuring the Safe Use of Medications

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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Regulatory News

Pharma and Regulatory News Sep 22

New ZLG Document on Transport Verification Published At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz

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Outsourcing Pharmacovigilance to CROs: Benefits, Challenges and Best Practices

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

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