- Pharmacovigilance (PV) which is a lifecycle management of drug safety is grown into a core area of clinical trial service

- LSK Global PS has established a pharmacovigilance agency in the EU for smooth management and report of safety information in compliance with strict European regulations on pharmacovigilance  

- Aimed at making a leap forward to a global PV center through the first establishment of an agency in the EU as a domestic CRO since the introduction of the PV Unit

LSK Global Pharma Services Co., Ltd. (LSK Global PS), a leading contract research organization (CRO) in Korea announced last Tuesday it has set up an EU pharmacovigilance (PV) agency in Warsaw, Poland, for the first time as a domestic CRO.

The PV agency established in the EU by LSK Global PS this time will manage and report the safety information of the clinical trials conducted in European countries when multinational clinical trials are conducted in domestic and foreign countries. The EU is the region where the strictest regulations on pharmacovigilance are applied and the safety information should be managed and reported in compliance with more subdivided regulations than in other regions.

With the establishment of a PV agency in the EU, LSK Global PS plans to expand its business scope to conduct PV audit not available by domestic CROs yet, prepare the Pharmacovigilance System Master File (PMSF) which is a system storing and managing all the documents relevant with PV and making them available to be submitted for audit and inspection, and directly report safety information, etc. to the European Medicines Agency (EMA).

Pharmacovigilance refers to the process of drug safety management identifying, evaluating, managing, and preventing the risks of pharmaceutical products throughout their lifecycles from development to marketing authorization and post-marketing stages in a continuous manner. The importance of PV system is increasingly getting strengthened since the properly equipped PV system can identify the risks associated with drugs and minimize the risks that may occur to patients.

Korea joined the International Council on Harmonization (ICH) as a full member in November 2016 and has been imposing the council’s standards in each area including manufacturing and conducting clinical trials for locally-produced pharmaceutical products. In particular, with the strengthened regulations on pharmacovigilance, its importance is being more emphasized.

LSK Global PS has been providing PV services including management of safety information on the medicines marketed abroad by domestic pharmaceutical companies by first organizing a dedicated PV Division in 2012 as a domestic CRO. LSK Global PS is the only domestic CRO which has owned professional manpower (4 persons as of May, 2019) qualified to directly report safety information to Eudravigilance (drug safety management system in Europe) of the EMA since 2016 making its reporting available in a professional and prompt manner