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• PSURs are pharmacovigilance documents that provide risk-benefit balance assessment. • The notion of PSUR is to offer a wide and complex evaluation of risk-benefit balance of a medicinal product. • PSUR reporting first came into existence in 1992. • Purpose of PSUR is to provide an update of global safety experience with a specific pharmaceutical. • It is imperative to consult the guideline on good pharmacovigilance practices (GVP) while preparing PSUR. • MAHs are supposed to submit all PSURs in EU to the central PSUR repository. To Continue Reading : https://bit.ly/34ViVDb pharmacovigilance Services : https://bit.ly/2wM7IIH Contact Us: Website : https://bit.ly/33Fwsye Email us: sales.cro@pepgra.com Whatsapp: +91 9884350006
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PharmExpert LLC provides a comprehensive range of international pharmacovigilance services to meet your global needs in the territories of Azerbaijan, Belarus, Georgia, Russia, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Ukraine, Uzbekistan. QPPV and Local QPPV PSMF Management Literature Monitoring and Aggregate Reporting (PSURs, DSURs) Regulatory Intelligence Monitoring ICSR Management and Assessment of Benefit-Risk Ratio Local Contact Person for Pharmacovigilance (LCPPV) Risk Management Plans (RMPs) and Risk Minimization Activities Pharmacovigilance Audit and Inspections Pharmacovigilance Trainings Safety Database and Signal Management Medical Information Requests Post-Authorization Safety Studies (PASS) Outsourcing of Pharmacovigilance System. No matter where your product is marketed in CIS/EAEU, our dedicated team ensures compliance with country-specific regulations, providing end-to-end support throughout the product lifecycle.
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product. • Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971. • For medicinal products the risk management documents/plan is achieved by • If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP) To Continue reading : https://bit.ly/3e1harA
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1. A novel process where European Medical Agency offers a new service. 2. The service is focused around medical literature monitoring. 3. This service is also a vital step to ensure that there is no duplication of negative reaction reports. 4. This service came into effect from 1st September, 2015. To Continue Reading : https://bit.ly/39C4iVW Pharmacovigilance Literature Search Services - https://bit.ly/2wM7IIH Contact Us: Website : https://bit.ly/33Fwsye Email us: sales.cro@pepgra.com Whatsapp: +91 9884350006
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