14 Jun Global Pharma Key Opinion Leader
ZM CRO GROUP company President Dr. Yuri Zaretsky has recently started collaborating with Korea Health Industry Development Institute (KHIDI) as an official consultant for Korean pharmaceutical and biotechnology companies – Global Pharma Key Opinion Leader (GPKOL).
As GPKOL Dr. Zaretsky is focused on the following issues in clinical trials and post-marketing period of drug lifecycle:
– Medical Review: Providing high quality creative solutions for all phases of trial such as line-listing review, participation in DSMB, IEC/IRB meeting, etc.
– Regulatory Affairs: Having applied knowledge and deep understanding of local (Roszdravnadzor in Russia, CFDA in China) and global regulatory requirements.
– Audits: Conducting along with regulatory authorities participate in assessment of existing drug safety systems
– Safety Database: E2B, EudroVigilance compliant, and specific Russian regulatory requirements.
– Drug Safety: Establishing and updating drug safety profile in clinical trials and post-marketing such as case identification, validation, medical coding, ICSR submission, RMP and PSUR, etc.