LSK Global PS Provides Pharmacovigilance ServicesComplying to the EMA Standards

- LSK Global PS upgradingcurrent PV electronic report system to comply with EMA’s new ICSR E2B(R3)implementation

- Expected to provide higher level of service forconstantly strengthening global pharmacovigilance environment.

[November 22, 2017] South Korea’s leading contract research organization(CRO) LSK Global PS (LSK Global Pharma Services Co., Ltd.) announced to provide stronger pharmacovigilance(PV)services meeting the standards of the European Medicines Agency’s (EMA) newlyimplemented Eudravigilance Data elements (E2B(R3)) of the Individual CaseSafety Report (ICSR) Guideline which is going live on November 22n^d.LSK Global PS is expected to provide pharmacovigilance services that meetsglobal standards.

In 2012, LSKGlobal PS became South Korea’s first CRO to provide pre- and post-marketing PVservices with the establishment of its own PV division. In addition, LSK GlobalPS is the only CRO to be equipped with 4 PV professionals (as of April 2017) qualifiedto complete the training and evaluation of the EMA’s Eudravigilance ICSRelectronic report and XEVMPD. For reference, a minimum of 1 qualified personmust reside in the reporting entity (company) to proceed with EMA safetyreport. Further, LSK Global PS is scheduled to upgrade its currentpharmacovigilance system Aris Global Safety Database to E2B(R3) in accordancewith the new Eudravigilance System.

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