Pharmacovigilance

The pharmacovigilance team of R&G is one of the earliest teams among CROs in China, which has begun to undertake the literature search services in Asia for European pharmaceutical products since 2019, and reported to the EMEA at that time through CIOMS I, which is in line with international standards in one step. At present, the department is divided into four functional areas, including Case handling, PV doctors, PV system, and PV quality control, and has reasonable division of labor, training in place, rich experience, reliable quality.

Over the past three years, the PV department has handled more than 230 projects covering PV activities throughout the lifecycle of the drug, with therapeutic fields such as oncology, cardiovascular, PD-1, Car-T, and cell therapy, and the scope of services includes all those required by domestic regulations, generally adopted by the industry, such as PSMF, RCP, RMP, ICSR processing, SUSAR Gateway reporting, DSUR, PSUR, PBRER, ISS, CTD2.7.4, CCSI, CCDS, PASS, DIM, signal monitoring and risk management, RSI, eCTD, etc.

Excellent performance in both clinical trials and post-marketing fields:

Led many projects involving SUSAR cross-reporting at home and abroad;

Early use four major PV systems in the industry;

Completed complex DSUR covering approximately 50 clinical trials;

Successfully operated the intensive monitoring benchmarking projects in the industry;

Actively supported and participated in the adoption of new PV system by NMPA;

PV team has a rigorous and effective quality management system to ensure high quality standards.