Entries by Evgenii Tkachenko

X7 Research Pharmacovigilance services

Dear colleagues, X7 Research company offers you to get acquainted with some types of pharmacovigilance services. QPPV services: Establishment and maintenance of PV system Development of a new PSMF, or peer review of your existing system, maintenance of the PSMF Case Management Periodic reports (PSUR, DSUR) Risk Management (RMP) PV database Signal Management PV Training […]

What is bioequivalence

It is known that a lot of the drugs sold in Russia are not original drugs, but their reproducible counterparts, which is due to much lower costs for the organization of production and market entry in comparison with the original, new drugs. Big pharmaceutical companies are investing heavily in the development of new medicines. This […]

Pharmacovigilance system audit

Dear colleagues, X7 Research invites everyone to join a FREE webinar about pharmacovigilance. The topic of the upcoming webinar is “Pharmacovigilance system audit”. On the webinar we will discuss: Basic regulatory requirements for the pharmacovigilance system organization of the registration certificate drug holder Necessary components that make up the pharmacovigilance system Quality system of pharmacovigilance […]

The record of the webinar “Requirements to the authorized person for pharmacovigilance in the EAEU” is available

Dear colleagues, last Friday a webinar “Requirements to the authorized person for pharmacovigilance in the EAEU” was held. Below is a brief outline of the webinar: The APP appointment Requirements for APP education Functions of an authorized person Do you have to appoint different APPs in each country where the drug is registered? And much […]

Trelegy – a new drug from GSK

Facing the prospect of generic competition to respiratory superstar Advair—and as the blockbuster’s sales falter under pricing pressure—GlaxoSmithKline is pushing to grow new drug Trelegy Ellipta by seeking an expanded indication at the FDA. Along with partner Innoviva, GSK applied for approval for Trelegy as a maintenance treatment of airflow obstruction and to reduce exacerbations […]

Drug-resistant infections: WHO’s report and poor prognosis

The new report of the World Health Organization (WHO) says that there are only few treatment options for some of the most widespread drug-resistant infections. That’s why the development of new antibiotics is so urgent now. However, the WHO found out that there are only a few antibiotics under development which can possibly overcome drug […]

FDA aims to better inform physicians about biosimilars through launching a new educational course

Drugs prescription may cost a lot and it has always been an issue. However, now we can observe quite a big market of cheaper biopharmaceutical products called biosimilars. This market is constantly growing leading to more competition and choices for patients. Biosimilars are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made […]

Requirements to the authorized person for pharmacovigilance in the EAEU

Dear colleagues, X7 Research invites everyone to join a FREE webinar about pharmacovigilance. The topic of the upcoming webinar is “Requirements to the authorized person for pharmacovigilance in the EAEU”. On the webinar we will discuss: The APP appointment Requirements for APP education Functions of an authorized person Do you have to appoint different APPs […]

Development and registration of medicines in accordance with the principles of good practices GxP

Dear colleagues, we invite you to participate in the II-nd scientific-practical conference with international participation “Development and registration of medicines in accordance with the principles of good practices GxP”. Date: November 29, 2017, from 11:00 to 16:30. Registration of participants from 10:30 to 11:00; address: 117246, Moscow, Naychnyi proezd, 20, building 2, Technopark Slava. Conference […]

The record of the webinar “The requirements of Good Clinical Practice (GCP) for the Investigational Drug circulation” is available

Dear colleagues, last Friday a webinar “The requirements of Good Clinical Practice (GCP) for the Investigational Drug circulation” was held. Below is a brief outline of the webinar: Basic terms and definitions; The life cycle of the study drug within the CT; ID circulation: production, distribution, return and destruction of ID; The document circulation at […]