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: firstname.lastname@example.org with a subject line: “webinar application” and the title of the webinar.
Feel free to familiarize with technical requirements for the webinar system at https://gilsinp.ru/ For all questions, please contact: email@example.com
- The Formulary of Russian pharmaceutical manufacturers by SID & GP is a tool much in demand by the industry
- A business meeting between the EAEU’s ISPE and the senior management of ISPE was held in Dublin
- Based on the results for 2018, 0.11% is the share of the drugs imported from Latin America
- The Russian GMP inspectorate signed an Agreement on Cooperation with the Cuban CECMED
- The Russian «Data Integrity & Computer System Validation» Guidelines were presented at the ISPE session