Event Information

Time：October 27, 2014 (Monday)

Place：TRPMA Conference Room
（1F, No. 465-1, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei City 11557, Taiwan）

For the second class of the “Safety Issues Concerning New Drug Development”, the TRPMA invited Dr Chen Min-Chu, a former head of the drug safety department of the US FDA, to give a lecture on how to establish a safety/ pharmacovigilence system in a company.

Dr Chen briefed the audience on the drug withdrawal cases between 2001 and 2010 in the US. Those cases were all voluntary withdrawals. Firstly, the US FDA raised its concerns over safety and discussed the concerns with the drug companies who then decided to withdraw the products on a voluntary basis. Dr Chen stressed that the competent authority and drug companies should establish an effective drug safety monitoring system. Dr Chen also pointed out the importance for drug companies to establish a safety department, appoint staff in charge of drug safety issues and establish an SOP for handling drug safety issues.

At the end of the class, Dr Chen discussed the future development of the drug safety monitoring system in Taiwan. Drug companies also shared their safety policies and talked about the problems encountered. Dr Chen hopes drug companies could collaborate in working out the direction for future development.

The TRPMA invited Dr Chen Min-Chu to talk about “How to establish a safety/ Pharmacovigilence system.”