GCCL Director Yoo-hwa Choi gave a lecture on the theme of 'Pharmaceutical Licensing Strategy' in the 2025 drug R&D planning and in-depth program.

Through this lecture, we guided the full-time approval review process for drugs, explained the application process for approval of clinical trial plans, change approval, and related reports conducted through the Food and Drug Administration's Drug Safety Country, and presented the product approval, product reporting, and post-marketing safety management methods. In addition, we explained the manual for the use of the drug safety country and provided how to register and manage clinical trials through PRS. In particular, we established a drug licensing strategy by introducing the experience of successfully obtaining approval and product approval for a new drug from bio-listed companies and clinical trial sample analysis institutions and their know-how.

For more information, please contact GCCL (GCCL@gccorp.com ) or  한국신약개발연구조합.