Local Pharmacovigilance in CIS, EAEU region
Local Pharmacovigilance services in Azerbaijan, Belarus, Georgia, Russia, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Ukraine, Uzbekistan
PharmExpert LLC provides local pharmacovigilance services to its clients in line with a global, regional and local levels PV guidelines/Good Pharmacovigilance Practices (GVP). Marketing authorization holders/Pharmacovigilance providers may delegate following services to Us:
– Development and maintenance of Pharmacovigilance System Master File (PSMF)
– Appointment of QPPV (Qualified Person responsible for PV)/Local QPPV and QPPV/Local QPPV back-up
– Weekly literature monitoring of scientific-medical, non-medical sources, internet or digital media for safety information search at a local and global levels
– Weekly regulatory intelligence monitoring of Health and Regulatory Authorities for safety information and regulatory updates at a local and global levels
– Collection, processing, evaluation, regulatory reporting, storage and archiving of Adverse Events (AE) and other safety related information from any sources
– Development of aggregate reports: Periodic Safety Update Reports (PSUR)/ Periodic Benefit-risk Evaluation Report (PBRER), Development Safety Update Report (DSUR)
– Development of Risk Management Plan (RMP)
– Assessment of the benefit-risk ratio of the MP
– Development and conduction of PV trainings
– Conduction of external audits
– Appointment of LPPV (Local Person for Pharmacovigilance) and LPPV back-up in the MP’s authorization countries
– Safety database maintenance
– Signal detection and management
– Safety communication
– Managing medical information requests obtained from Consumers/HCPs/Sales representatives
– Conducting post-authorization safety studies (PASS)
– Interaction with regulatory authorities on drug safety issues
– Pharmacovigilance consulting services on issues in the drug safety
– Obtaining, processing and reporting information on safety in PASS
– Outsourcing of entire Pharmacovigilance System.
Materiovigilance deals with the identification, collection, reporting, estimating the undesirable occurrence and the possible management of adverse events associated with the use of medical devices, thus promoting patient health by preventing its recurrences.
PharmExpert offers in this field following services:
– Collection, investigation, and assessment of Adverse Device Effects (ADE) / Medical Device Incidents (MDI)
– Submission of Adverse Device Effects (ADE) / Medical Device Incidents (MDI) to manufacturer
– Monthly compliance and status reporting
– ADE and MDI Reconciliation
– Preparation of Periodic Summary Reporting
– Preparation of Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
– Periodic literature search in scientific literature to identify safety information and adverse reactions of products.
Nutravigilance refers to the science and activities relating to the detection, assessment, understanding and prevention of adverse events related to the use of a food, dietary supplement, or medical food.
List of services:
Appointment of Local Contact Person for Food Supplement Vigilance
– Comprehensive management of adverse events of food supplements reported by consumers, health professionals or authorities
– Submission of serious adverse reactions to the manufacturer
– Periodic search of safety information of food supplement products in scientific literature
– Food supplement Product Safety Report
– Signal Detection and Management.
Cosmetovigilance is the ongoing and systematic monitoring of the safety of cosmetics in terms of human health. The aim is to detect adverse events of cosmetic products, and to prevent adverse effects by taking appropriate measures.
List of services:
– Appointment of Local Contact Person for Cosmetovigilance
– Comprehensive management of adverse events of cosmetic reported by consumers, health professionals or authorities
– Submission of serious adverse reactions to the manufacturer
– Periodic literature search in scientific literature to identify safety information and adverse events of cosmetic products
– Cosmetic Product Safety Report
– Signal Detection and Management.
Veterinary Pharmacovigilance is defined an activity to continuous safety monitoring by identifying and analysing any negative effects from the use of veterinary medicines that may occur in animals.
List of services:
– Appointment of Local Contact Person for veterinary medicines
– Comprehensive management of adverse events of veterinary medicines reported by consumers, health professionals
– Submission of serious adverse reactions to the manufacturer
– Periodic search of safety information of veterinary medicines in scientific literature
– Signal Detection and Management.
About Local Pharmacovigilance Services Provider
The company was founded on Feb 2019 by a team of specialists with in-depth knowledge and practical experience in various pharmaceutical fields such as manufacturing, clinical trials, regulatory affairs, as well as medicine, and business.
PharmExpert LLC is primarily engaged in providing a complete range of drug safety services to Marketing Authorization Holders and Pharmacovigilance Service Providers.
PharmExpert recognizes the critical importance of Good Pharmacovigilance Practices (GVP) for patient safety. The Company views this aspect as a primary responsibility in its pharmacovigilance operations, and has adopted appropriate quality standards to ensure public health and customer satisfaction.
PharmExpert has established, maintains and applies a Quality Management System in compliance with the international standard ISO 9001:2015 and GVP guidelines.
The key aim at all times is to ensure prompt and effective functioning of all the Company’s processes and activities.
In line with this strategic vision, our main objectives are:
– To provide adequate, reliable and regulatory compliance services
– Optimize the performance of Company’s business and pharmacovigilance processes by maintaining continuous improvement of Quality Management System
– Effectively address and satisfy any existing and projected needs of educational, training and professional development needs of employees and other stakeholders of the Company
– Build client loyalty by meeting or exceeding our customer expectations and contractual obligations.
Local Pharmacovigilance Services Stat
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Local Pharmacovigilance Services. Why PharmExpert?
We care for our clients’ business as our business. We think and act like business partners, not academic advisors. We share our clients’ aspirations, work to understand their reality, and align our incentives with their objectives — so they know we’re in this together.
Continuous Improvements
We are a company that optimizes the performance of our business and pharmacovigilance processes by maintaining continuous improvement of Quality Management System.
Public Health
We are a company that protects patients and consumers from the adverse drug reactions.
Customer satisfaction
We are a pharmacovigilance consulting services provider that designs and builds client loyalty by meeting or exceeding our customer expectations and contractual obligations.
Quality Services on Pharmacovigilance
We are a company that provides adequate, reliable and regulatory compliance services.
Innovation Solutions
We are a company that creates and uses new ideas and methods.
Staff training and development
We are a company that effectively addresses and satisfies any existing and projected needs of education, training and professional development of employees and other stakeholders of the Company.