Pharmacovigilance services in the Republic of Belarus and the EAEU
Activities aimed at identifying, assessing, understanding and preventing adverse drug reactions
Pharmacovigilance services in the Republic of Belarus and the EAEU
Activities aimed at identifying, assessing, understanding and preventing adverse drug reactions
leading companies have entrusted us to implement their pharmacovigilance projects in Belarus and the EAEU
Would you like to get a consultation? Submit a request online
What services do we provide?
PromoSolution provides a full range of pharmacovigilance services, including pharmacovigilance system organization and all pharmacovigilance-related processes management within the territory of the Republic of Belarus and the EAEU countries.
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Pharmacovigilance contact person services within the territory of the Republic of Belarus:
- Management of collection, processing and analysis of AEs/SAEs reports
- Management of a local pharmacovigilance system
- Management of a call center 24/7 to receive messages
- Interaction with the regulatory authority and with customer’s headquarters on pharmacovigilance issues
- Weekly/monthly monitoring of local literary and Internet sources
- Monthly reports rendering on local pharmacovigilance activity
- Personnel training on pharmacovigilance issues for customer companies
- Documentation of the PSUR submission procedure
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Services of Qualified Person Responsible for Pharmacovigilance within the territory of the EAEU countries:
- Management of collection, processing and analysis of AEs/SAEs reports
- Management of a pharmacovigilance system within the territory of the EAEU countries
- Management of a call center 24/7 to receive messages
- Interaction with the regulatory authority, with customer’s headquarters and with contact persons within the EAEU countries on pharmacovigilance issues
- Weekly/monthly monitoring of literary and Internet sources
- Periodic Safety Update Report generation and submission
- Risk Management Plan generation and submission
- Personnel training on pharmacovigilance issues for customer companies
- Monthly reports rendering on pharmacovigilance activity
- Implementation of additional risk minimization measures
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Individual temporary services are also possible not within the scope of Pharmacovigilance Contact Person and/or Qualified Person Responsible for Pharmacovigilance:
- Risk Management Plan generation
- Periodic Safety Update Report generation
- Pharmacovigilance System Master File generation
- Compilation of preclinical/clinical overviews of safety of drug products; management of the PSUR submission procedure
Do you have any questions?
Do not hesitate to contact us in any convenient way and we will advise you on any issue you may have.
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Full range of regulatory services
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Pharmacovigilance services in Belarus and the EAEU countries
Product distribution
User testing of PL