2020-03-19

EffPha held a symposium with CPMDA

Symposium-Unlocking the EFFICIENCY in Drug Development: Begin with the End in Mind was held by EffPha and CPMDA

In the process of new drug development, how to optimize the limited resources, time, and money has been the focus of pharmaceutical companies. Among the important steps for improving efficiency and creating value, in addition to setting up the right strategy and goal, the quality and efficiency of clinical operation and good utilization of data management platform could all improve the efficiency and probability of success. Besides, how to quickly gain approval from the regulatory authorities is also a key to enhance the efficiency of drug development.

EffPha and CPMFA worked together to hold this symposium, for sharing useful information with the pharmaceutical and CRO companies in Taiwan, to help the companies understand the review standards and essentials of the regulatory authorities in order to get the submission package well prepared.

In this symposium, EffPha invited several experts with extensive drug development experience to share the strategies for improving efficiency of new drug development. EffPha’s US Regulatory Representative, Dr. Nancy Motola, shared about the essentials of US regulatory submission and how to communicate smoothly with FDA. Dr. Ling Su, the Venture Partner with Lily Asia Ventures, was also invited to share the key changes of regulations in China in recent years and what the China authority focuses on when reviewing submission packages. The panel discussion session was hosted by EffPha’s president and CEO, Dr. Frank Shen. The Chief Executive Director of CDE (Center for Drug Evaluation), Dr. Churn-Shiouh Gau, and Dr. Arnold Chan, the Director of NTU Health Data Research Center, as well as Dr. Du-Shieng Chien, the President and CEO of TaiRx, also a PK/ADME expert were invited to the panel to discuss about the trend and methods to improve efficiency of new drug development and provide suggestions on how to deal with the challenges faced in multi-national product development.