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PHARMACOVIGILANCE
Organization of pharmacovigilance in the EAEU and CIS countries. This is a scientific and practical activity to identify, assess, understand, and prevent undesirable consequences of drug administration.
SERVICES INCLUDE
WITH THE QPPV SERVICE (QUALIFIED PERSON FOR PHARMACOVIGILANCE), WE OFFER:
– Maintenance and management of the pharmacovigilance (PV) system
– Acting as a qualified person responsible for PV (QPPV)
– Providing a 24/7 hotline for round-the-clock access to the QPPV for the Competent Authority (CA)
– Consultation and support for the Marketing Authorization Holder (MAH) regarding PV in the EAEU, including any communication with the CA regarding PV
– Maintaining the quality system of the PV system
– Documenting the PV system
– Introductory and ongoing PV training for MAH specialists and partners whose activities may impact PV system performance and PV functions
– Conducting PV system audits (including introductory audits of service providers) and supporting MAH-assigned audits
– Managing the MAH’s PV account on the CA’s website
– Periodic reporting for MAH (form and frequency agreed upon)
– Periodic updates and maintenance of EAEU Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreements (SDEA), and other PV-related documents
– Sending PV documents by express mail/hand delivery to the regulatory authority
– Translation services for documents into English/Russian
– Systematic review of local literature and internet sources
– Handling adverse event (AE) reports, completing notification forms, and submitting to MAH and, if necessary, to CA
– Supporting the submission process of RMPs upon CA request
– Monitoring the schedule and supporting the submission process of PSURs to CA
– Periodic reporting for MAH (as agreed)
WITH THE LDSUSERVICE (LOCAL DRUG SAFETY UNIT), WE OFFER:
– Acting as a qualified local drug safety unit (LDSU)
– Providing a 24/7 hotline for round-the-clock access to the QPPV for the Competent Authority (CA)
– Communication with CA regarding PV
– Maintaining the quality system of the PV system
– Documenting the PV system
– Conducting PV system audits (including introductory audits of service providers) and supporting MAH-assigned audits
– Managing the MAH’s PV account on the CA’s website
– Periodic reporting for MAH (form and frequency agreed upon)
– Supporting MAH in providing data necessary for updating and creating PSMF EAEU, SDEAs, and other PV-related documents
– Sending PV documents by express mail/hand delivery to the regulatory authority
– Translation services for documents into English/Russian*
– Systematic monitoring of local literature and internet sources
– Handling AE reports, completing notification forms, and submitting to MAH and, if necessary, to CA
– Supporting the submission process of RMPs upon CA request
– Monitoring the schedule and supporting the submission process of PSURs to CA
– Periodic reporting for MAH (as agreed)
SERVICES INCLUDE
ADDITIONAL PHARMACOVIGILANCE SERVICES
We guarantee comprehensive and highly qualified support, adherence to deadlines, and process control:
We will calculate the final cost and timing of the procedure upon your request
What is pharmacovigilance?
Pharmacovigilance is a system of monitoring and controlling the safety of medicines to protect public health. Pharmacovigilance involves monitoring the quality, efficacy, safety and appropriate use of medicines.
The main objective of pharmacovigilance is to ensure the safe use of medicines and to identify and prevent adverse reactions.
PharmAssistance LLC Pharmacovigilance Services
For over 12 years our company has been performing pharmacovigilance of domestic medicines, as well as medicines registered in the CIS and EAEU.
To learn more about the cost of pharmacovigilance services you can call +375 (29) 150-26-02, +7 (495) 181-99-21. You can also apply for a commercial offer by mail to sales1@pharmassistance.by.
Organization of pharmacovigilance
Pharmacovigilance is of great importance to society as it helps to prevent adverse effects and complications associated with the use of medicines. Pharmacovigilance improves the safety of medicine therapy and reduces the risk of adverse reactions. Therefore, it is mandatory for all holders of marketing authorizations for medicinal products to maintain a pharmacovigilance system.
The team of pharmacovigilance experts is highly qualified and has extensive experience in the field of pharmacology. Focused attention, accurate monitoring, and a high understanding of the responsibility of the work performed are the qualities that our experts possess in addition to professional knowledge. Pharmacovigilance services of our company comply with the requirements and laws of the CIS and EAEU countries.
What is included in pharmacovigilance?
Pharmacovigilance is a complex system involving a number of subtasks, the most important of which are:
- Expert advice and preparation of a list of recommendations on pharmacovigilance issues;
- Provision of individual pharmacovigilance services or “turnkey” pharmacovigilance of a medicinal product;
- Audit (peer review) of the pharmacovigilance of a third party company;
- Ensuring a smooth pharmacovigilance process as an authorized person or contact person.
Main tasks of pharmacovigilance
The main tasks of pharmacovigilance include:
- Monitoring the quality of medicines. Verifying that medicines meet quality, safety and efficacy standards.
- Evaluating adverse reactions and side effects. Tracking information on adverse drug reactions and taking action to prevent them.
- Educating healthcare professionals and patients. Conducting information campaigns on the safe use of medicines and training medical personnel in new methods of assessing the safety of medicines.
- Improving the regulatory framework for pharmacovigilance. Develop and implement laws and regulations governing drug safety activities.
Pharmacovigilance by PharmAssistance LLC: Why us?
Pharmacovigilance is an important part of the healthcare system. We, more than anyone else, understand and accept the responsibility for the accuracy and reliability of pharmacovigilance of medicines. Our corporate principles are clearly regulated and in line with the legislation in the pharmacovigilance niche.
It is important for us to do our work perfectly, taking into account all the wishes and requirements of our clients. Before starting work with a new client, our team studies the specifics of the business and the market requirements.
We have an unspoken goal – to create long-term partnerships based on trust and mutually beneficial cooperation. Any loss of quality in pharmacovigilance services is unacceptable to us.
By choosing PharmAssistence, LLC, you get:
- the experience and knowledge of a team of professionals with more than 12 years of experience in pharmacovigilance;
- qualified assistance in solving pharmacovigilance problems of any complexity and prompt information support 24 hours a day, 7 days a week;
- reliable intermediary for interaction with authorized bodies of the EAEU and CIS;
- guaranteed results and quality of pharmacovigilance, for which we are ready to guarantee.
You can order pharmacovigilance activities from PharmAssistance LLC, get more information about this service, as well as discuss ways of cooperation and partnership with us by phone +375 (29) 150-26-02, +7 (495) 181-99-21.
