Pharmacovigilance
Organization of pharmacovigilance within the Russian Federation territory is an obligation of the drug manufacturer. It assumes quite complex and thorough work on formation of the team, building the pharmacovigilance system on the whole and maintaining its high-quality implementation. To control safety of the use of their drugs, manufacturers and MA holders are able to outsource, in part of fully, the activity of pharmacovigilance and submission of the information set forth by the legislation to regulatory authorities. Such initiative is an excellent solution in case the company has no staff responsible for the pharmacovigilance system and is not eager to allocate additional resources for such activities.
Services of an authorized person for pharmacovigilance
-
Preparation of a safety report for a medicinal product, a periodic safety report, and a risk management plan.
-
Pharmacovigilance system master file management.
-
Development of SOPs for pharmacovigilance system
-
24-hour hot line
-
Monitoring of information on adverse events, including the Internet, digital media, Russian and foreign medical literature.
-
Investigation of cases of adverse reactions
ClinPharmDevelopment
Is an independent contract research organization successfully implementing preparation for and carrying out of clinical trials of all phases within the territory of Russia and EAEU countries.
We employ more than 30 people, including 6 PhD degree holders. All employees involved in trials have a university degree in medicine or pharmacy, GCP/GLP certificates, and broad experience of participating in clinical trials.
The company successfully cooperates with the centers of the Russian Federation for preclinical research that meet all modern requirements, localized in Moscow, St. Petersburg, Yaroslavl."
Report about аdvers event
-
What cases should be reported to the pharmacovigilance service?
There are no restrictions on the type of medications and/or adverse reactions for messages from consumers. You can send a message to the pharmacovigilance service if a case has arisen during the medical use of drugs:
- Change in well-being after taking the drug;
- Suspicion of drug inefficiency;
- Unexpected effect not described in the instructions for medical use of the drug;
- Detection of counterfeit products;
- Overdose when using the drug;
- Drug abuse;
- The occurrence of a reaction when using the drug in combination with other medications.
-
When to send a message?
The message should be sent as soon as possible after the information has become known to you.
-
Where and how to apply?
Any adverse reaction that you suspect after using any drug in the Yaroslavl region can be reported to the Pharmacovigilance Department of LLC «KFD»: Yaroslavl, uya. Uglichskaya, 68; Office 1
By calling the toll-free hotline: 8-800-234-61-16
By email address: safety@cphd.ru
Fill out the form on the website: Report about аdvers event to the Federal Service for Healthcare Supervision of the Yaroslavl region: Yaroslavl, Svobody str., 93 a
By phone: +7 (4852) 45-70-95
By fax: +7 (4852) 45-71-07
By email address: info@reg76.roszdravnadzor.ru