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Taiwan FDA held TFDA Town Hall Session in Drug Information Association (DIA) 2018 Global Annual Meeting 【Date:2018-06-27】 unit:藥品組

 

Taiwan FDA (TFDA) joined delegations of the government agency, clinical trial centers, research institutions and drug companies to attend the DIA annual meeting. For the first time, TFDA held TFDA Town Hall session in the DIA annual meeting to share perspectives of government agency. Center for Drug Evaluation (CDE) also set up booths to exhibit Taiwan’s competitive edge in clinical trials and regulatory environment (TaiwanClinicalTrials.TW). Through the interaction with international pharmaceutical affairs, we could attract international cooperation with other regulatory agencies to invest in new drug research and development in Taiwan and boost the development of other related industries.

Drug Information Association (DIA) has served as an international organization and their members include: government regulatory agencies, science, research, and development, CRO companies worldwide. The DIA annual meeting is the largest meeting of drug developers, manufactures and regulatory agencies that provides opportunities in advanced scientific and medical innovation. 2018 Global Annual Meeting was held during 24th-28th June at the Boston Convention & Exhibition Center in USA. During the session of TFDA Town Hall, Shou-Mei Wu, the Director General for TFDA, highlighted the role of TFDA in regulatory management of drug development. James Chih-Hsin Yang, the Director of Department of Oncology at National Taiwan University Hospital, then proceeded to share the challenges in conducting multi-regional clinical trials and interpreting data. Churn-Shiouh Gau, the Executive Director of Center for Drug Evaluation, in her speech demonstrated the usage of real world evidence in regulatory decision making. The topic of Annie Tsu-Hui Liu, the Director of Office of the Board of Science and Technology at Executive Yuan, was about development of pharmaceutical industry in Taiwan. Other presentation topics in the profession poster session. included: prior assessment consultation for cell therapy products to enhance the investigational new drug application quality in Taiwan, the cost effectiveness of metastatic melanoma treatment in Taiwan, and an adaptive seamless phase I/II design in drug development for binary endpoints

In order to promote the communication in regulatory science, the TFDA and CDE organized the informal “Taiwan Night” event, enhancing the relationship with foreign regulatory agencies, local pharmaceutical companies and Taiwan experts in the research. Present to officiate the event was the Executive Director of DIA, Angelika Joos, Corporate Vice President of PAREXEL International, Alberto Grignolo, and the Director of General of Taipei Economic and Cultural Office in Boston, Douglas Hsu. Drug regulatory experience-sharing and the practice application in Taiwan were internationally recognized.