Pharmacovigilance

Pharmacovigilance

As a domestic CRO, LSK Global PS is providing the pharmacovigilance services of managing the safety information on pre- and post-marketing medicinal products, medical devices, etc. through organization of the department specialized in pharmacovigilance for the first time. Putting top priority on the patients’ safety through a high level of pharmacovigilance, the pharmacovigilance service is performed in compliance with the ICH guideline and the domestic and global regulations updated frequently. LSK Global PS performs safety monitoring and reporting, and also carries out a task of preparing the reports based on the collected safety data such as the RMP(Risk Management Plan), DSUR(Development Safety Update Report), PBRER(Periodic Benefit-Risk Evaluation Report), etc. to be submitted to the domestic and foreign regulatory authorities. In addition, LSK Global PS is carrying out the tasks related to drug safety as a drug safety representative in terms of the pre- marketing clinical trials and post-marketing pharmacovigilance.

PHARMACOVIGILANCE_BROCHURE

Pharmacovigilance Experts

The pharmacovigilance experts of LSK Global PS consist of the healthcare professionals including medical directors, pharmacists, and nurses, and is the only CRO among the domestic CROs which has been staffed with experts(4 persons as of May, 2019) qualified to directly make a report on the safety information to the Eudravigilance(European drug safety management system) of the EMA since 2016 and can perform a task of reporting in a professional and prompt manner. LSK Global PS is also providing an outstanding pharmacovigilance service in foreign countries as well as in Korea through the establishment of a verified safety database.

Customized Pharmacovigilance Solution Provider

LSK Global PS provides customized solutions to fulfill the needs for projects and conforms to the all requirements for the relevant reports through close cooperation with clients, study sites, and regulatory authorities.
LSK Global PS owns the notification about completing the learning and assessment of the Eudravigilance ICSR electronic reporting and the XEVMPD, and provides the services for registration of Eudravigilance users and electronic reporting of safety information based on this. In particular, LSK Global PS supports the task of registering information on investigational medicinal products and reporting the SUSARs that have occurred during clinical studies electronically as the responsible person for Eudravigilance on behalf of clients, when any companies of non-European countries without owning a medicinal product approved in Europe plan to conduct clinical studies in Europe.

Establishment of LSK PV EU Branch Office

LSK Global PS established its pharmacovigilance branch office in Warsaw, Poland in May, 2019 for the first time among the domestic CROs. The LSK PV EU branch office performs the task of managing and reporting the safety information of the clinical studies in which any European country is included, when multi-country clinical studies are to be conducted in Korea and foreign countries. With the advent of the PV branch office established in Europe, LSK Global PS is extending its work scope to the PV audit which has not been performed by any domestic CRO yet, the preparation of the PSMF(Pharmacovigilance System Master File) which is a system allowing all the PV-related documents to be archived, managed, and submitted at the time of audit and inspection, the direct reporting of safety information to the EMA(European Medicines Agency), etc.

Process

Service Scope

Safety management

SAE processing

SOP development and management

PSUR/PBRER development

RMP development

ICSR processing

Regulatory requirement compliance and consulting

PV audit

Safety report production

Safety report production

RMP development

Literature surveillance

PSMF (PV System Master File)

Safety reporting in eudravigilance database

Local safety support regarding local PV legislation

Set-up and management of pharmacovigilance system

Experience

Study Types

1614121086420 Phase I Phase II Phase III Phase IV IIT Observation Study PMS Consulting Others

Therapeutic Area

Oncology Cardiovascular Orthopedics Neurology Respiratory Medical Genetics Vaccine Endocrinology Others 52 Projects(Updated on 2019.12.31)