Feb. 14, 2017 Webinar on “Pharmacovigilance in Eurasian Economic Union”
FSI State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade announces a webinar dedicated to Pharmacovigilance in the EAEU.
The webinar will highlight proper organization and operation of the pharmacovigilance system in pharmaceutical business.
We will review the key provisions of good vigilance practices (GVP) accepted in the EAEU, requirements to the authorized pharmacovigilance officer, regulations for developers and holders of drug registration certificates.
Special attention will be paid to the step-by-step algorithm in creating an effective pharmacovigilance system, including staff training.
Our experts will give recommendations on proper development of documents (master file of the pharmacovigilance system, periodic security reports, a risk management plan, paperwork to be submitted upon registration, necessary SOPs, etc.), and databases maintenance. We will also offer advice on organization of pharmacovigilance for developers of biomedical cellular products.
Proper reporting for regulators will be reviewed in detail among other issues necessary for preparation of upcoming inspections of the pharmacovigilance system in the pharmaceutical business.
The webinar will be conducted by Boris Romanov, Deputy Scientific Director of the Scientific Center of Medical Products Assessment of the Ministry of Health, PhD of Medical Sciences.
Time: from 10.00 to 11.30. Admission fee: 5 000 rubles.
For registered participants a recorded copy of the webinar will be available for viewing until February 17, 2017, 19:00.
Please fill out an application form and send it to: email@example.com with a subject line: “webinar application” and the title of the webinar.
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