Novotech is participating in the "Adapting to Change: What Pharma Companies Must Do to Prepare for RMP" panel discussion, addressing the full implementation of the Risk Management Plan (RMP) system as a replacement for the Post-Market Survey (PMS) system, which has now been abolished. This regulatory shift enhances post-market drug safety by requiring the MFDS to plan, implement, and evaluate risk mitigation measures beyond adverse event monitoring.
Novotech's regulatory experts, Hyun Kim (Country Managing Director, South Korea) and Jinah Lee (Associate Director, Regulatory Operations), will provide insights on:
- Understanding the expansion and implementation of the RMP system
- Practical considerations for active surveillance studies as an alternative to PMS
- Industry impact and strategic responses to ensure effective post-market safety management
Hyun Kim will deliver the opening remarks and introduce Novotech, highlighting its extensive regulatory and clinical research expertise.
Jinah Lee, an RA expert in Korea, will serve as the session's moderator.
They will be joined by leading experts, including Prof. Ju Young Shin (Sungkyunkwan University), Prof. Nam-Kyong Choi (Ewha Womans University), and Prof. Sun-Young Jung (Chung-Ang University) on the panel discussion to provide their insights as industry experts.
Register now to gain insights into these regulatory changes and industry best practices.