PatientDrug SafetySeminarHosted by Proswell Achieved Complete Success


Special Reports of 5thDIA China Annual Meeting
  On May 14, 2013, 5th DIA China Annual Meetingwasheld as scheduledin Beijing, Proswell Medical Company attended this meeting as exhibitor. A subject session with the theme of“Concern on the Drug Safety and Risk Active Control in Clinical Trial”was hosted in the meeting.
     Sean Zhao, who is the Vice President of Amylin Pharmaceuticals, Inc., delivered a keynote speech on “Establishment of Post Marketing Investigation System and Product Safety Standard Procedures and Risk Active Control”, to state the significance of establishment a point to point safety regulatory system for optimizing the drug safety; how to establish the standard operation procedures of safety operation, safety supervision, risk management and risk reduction measures in pharmaceutical enterprise, and how to cooperate; to state the major methods of post-marketing risk-benefit assessments, how to use these methods to meet the regulatory requirements of regulatory agency, manage and deduce the patient risk, and pursue the benefit for patients who are using the product and establish the measures for security their safety.
     Zhimin Yang, Minister of Chemical Drug Clinical Department I of CDE, stated the CDE review opinions for drug safety. Minister Yang address the concerns of protocol review, risk considerations at different stages of early and late phases of clinical trial, and the concerned problems in Approval Letter.
     Prof. Yuankai Shi, Vice President of Cancer Institute & Hospital, Chinese Academy of Medical Sciences, attended the meeting as an honored guest, he shared a lot of clinical trial experience of anti-tumor drugs. Susan Soong, CEO of Proswell Medical Company delivereda concluding speech, she would like to join colleagues around the industryto promote the healthy development of China CRO industry andmake contribution to the medicaldevelopmentof China, dedicatingto build an international brandserving for customers at home and abroadwhich is transferred from a national brand providing servicesmainly for domestic companies.