Event Information

Time: May 27, 2016 (Friday)

TRPMA invited Dr. Min-Hui Chen from Medigen Biotechnology Crop to give a speech about the principles and considerations for the design of the first in human (FIH) clinical trials of non-cancer new drugs. The contents include how to evaluate the pre-clinical data and risk factors, how to choose dosage, how to design the trial and the FIH requirements imposed in major regulatory countries. Dr. Chen also shared his experiences in executing FIH trials with the industry representatives and officials from TFDA and CDE.

Due to a wild interest in this topic, TRPMA is going to invite Dr. Chen to continue this talk. Information will be announced on the TRPMA website and facebook page.