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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 professionals, and researchers. Here is an elaboration on the vital pharmacovigilance guidelines mentioned:
The ICH develops guidelines for pharmacovigilance that aim to harmonize practices globally. These guidelines cover various aspects, including expedited reporting of adverse events, individual case safety reports (ICSRs), periodic safety update reports (PSURs), post-approval expedited reporting, and pharmacovigilance planning. The ICH guidelines contribute to standardizing pharmacovigilance practices across different regions and promoting the consistent assessment and reporting of drug safety data.
2. U.S. Food and Drug Administration (FDA):
Guidelines issued by USFDA play a critical role in ensuring drug safety and monitoring adverse events in the United States. These guidelines provide a framework for pharmaceutical companies, healthcare professionals, and regulatory authorities to effectively implement pharmacovigilance practices and comply with regulatory requirements.
3. European Medicines Agency (EMA):
In the European Union (EU), the European Medicines Agency (EMA) has developed a set of measures known as Good Pharmacovigilance Practices (GVP) to facilitate the performance of pharmacovigilance in the EU. GVP applies to marketing-authorization holders, the EMA, and medicines regulatory authorities in EU Member States. They cover medicines authorized centrally via the Agency as well as medicines authorized at the national level
4. World Health Organization (WHO):
The WHO plays a significant role in pharmacovigilance activities worldwide. It has established an integrated Pharmacovigilance team within the Department of Regulation and Prequalification (RPQ) to address the safety of medicines and vaccines. The WHO Global Advisory Committee on Vaccine Safety and the WHO Advisory Committee on the Safety of Medicinal Products meet regularly to discuss important topics related to pharmacovigilance. These committees provide expert guidance and recommendations on the safety of vaccines and medicinal products, contributing to global efforts to ensure drug safety.
These guidelines provide a structured approach for implementing pharmacovigilance practices, ensuring that adverse events and other drug-related problems are promptly detected, assessed, understood, and prevented. By adhering to these guidelines, regulatory authorities can determine the safety profiles of drugs more effectively, pharmaceutical companies can meet their regulatory obligations, healthcare professionals can make informed decisions regarding medication use, and researchers can contribute to the ongoing monitoring and evaluation of drug safety.
Overall, pharmacovigilance guidelines foster harmonization, standardization, and best practices in the field of drug safety, ultimately working towards the common goal of protecting public health and enhancing patient safety.
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