Due to the current epidemiological situation, the issue of developing and implementing additional measures to ensure the safety of participants in current and planned clinical trials, as well as consumers of medical products within the framework of post-marketing surveillance has become more relevant for the...
Contract Research Organization Nanjing YZ Clinical Trials & Consulting Co., Ltd. within an international group of companies ZM CRO GROUP www.zmcro.cn, with long-term (more than 20 years) experience of successful cooperation with the pharmaceutical companies within the multinational projects for the safety provision of MP invites to...
On November 14th, 2018, the president of ZM CRO GROUP, Yuri Zaretsky was engaged in the 7th International Forum «Clinical Trials in Russia» as a moderator of the Round Table «Safety monitoring system expansion». The forum was organized by the Adam Smith Institute and was...
Key words: Patient information leaflet (PIL), adverse reaction (AR), adverse event (AE), company core safety information (CCSI), summary of product characteristics (SmPC), unsolicited (spontaneous) reports (UR), solicited reports (SR), clinical trials (CT). Pharmacovigilance is a complex system that allows all parties involved in drug circulation to ensure medicinal products...
27th April 2018 the CDE has published the “Standards and Procedures for the Expedited Reports of Safety Data during Clinical Trials” (abbreviated as “the current standard and procedures”) on their website. According to this document, from 1st of May 2018 serious and unexpected adverse drug reactions...
According to the report of Xinhua News Agency, under the witness of Mr. Wang Yong, the State Councilor, the office of State administration for market regulation unveiled the official address at the address of No. 8 Sanlihe East Road, Xicheng District, Beijing at 9:30am on 10th...
Dear Сolleagues! It is our great pleasure to invite you to the webinar "5 KEY CHALLENGES OF PHARMACOVIGILANCE IN CHINA" presenting changes in pharmacovigilance practice after China joined ICH. Date: TBD Time: 2:00 PM (CET) Cost of Webinar: FREE Webinar language: in Chinese Webinar organizer: NJ YZ Clinical Trials & Consulting Co.,...
