The Clinical Trial Session of Chinese Symposium on Medical Oncology Hosted by ProswellAchievedComple

 

On 4th, July 2013, the 7th Chinese Symposium on Medical Oncology and the 2nd Annual Meeting of Chinese Society for Clinical Oncologistsweresuccessfully held at China National Convention Center. The Symposium added Clinical Trial Session for the first time, and concluded with perfect ending on 7th, July 2013 at Meeting Room 311B of China National Convention Center.

The session is hosted by Cancer Institute&Hospital, Chinese Academy of Medical Sciences and Proswell Medical Company, the Session’s theme is “Drug Risk/Benefit Considerations”, and we invited16 experts from investigator, regulatory agency, sponsor, CRO and clinical cancer research unitsat home and abroadto participate in this grand event.
The vice-president Mr. Yuankai Shi, who is the chairman of Symposium, said in his opening ceremony speech that the aim of holding Clinical Trial Session is to enhance emphasis on the quality of clinical trial,to recognize the significance of effectively control drug risk, to prompt the maximum of benefitconsideration. As well as providing a full communication platform for sponsor, drug regulatory agency, CRO and clinical research unit, if people reach a consensus, the new drug research and development would get twice the result with half the effort. The clinical trial is the most important part for new drug research and development, if the clinical trial was not done well, the foundation of drug launch is not solid.
The Session is divided into two modules and three periods, including expert speech and subject discussion. The first period is chaired by Susan Soong, the CEO of Proswell Medical Company, the speeches are given by Sean Zhao, vice-president of Amylin Pharmaceuticals, Qingli Wang, deputy minister of CDE and Qin Huang, deputy minister of CDE, to share the significance of post-marketing clinical study and multi-methods of post-marketing clinical study, as well as the latest requirements for IND review of CDE and data quality management of clinical study. The second period is chaired by Yinxiang Wang, the President of Zhejiang Beta Pharma, Yin Huang, the vice president of CSPCPharmaceutical Group Limited Pharmaceutical Division shared the practice and experience of post-marketing drug management of CSPC Pharmaceutical Group Limited, another speaker is Susan Soong, the CEO of Proswell Medical Company, she shared how to establish an effective pharmacovigilancesystem to ensure the clinical trial risk-benefit assessments.
The second module is subject discussion, which is chaired by ZhiqiangNing, vice president of Shenzhen Chipscreen Biological Technology Co., Ltd. In this module, the speaker and guests communicated with other participants and hadan in-depth exchange of views on the emphasis of drug risk/benefit considerationsfrom the different roles, and the focus of clinical trial risk/benefit considerations from different stagesaround the symposium theme. At the same time, the investigator, sponsor and CRO and related personnel of regulatory agency discussedthe views on how to avoid the risks in the process of clinical trials and protection of rights and interests of subjects at the session.
 
The Session is divided into two modules, including expert speech and subject discussion.
The Topics of Expert Speech Are As Follows (In Sequential Order)
Establish the Evidence-based Medicine Proof System Through The Research of Post-Marketing Drug Risk/Benefit Evaluation ( Sean Zhao)
Critical Questions of IND Review (Qingli Wang)
How to Improve The Data Quality of Clinical Trial (Qin Huang)
The Practice and Understanding of Post-MarketingDrug Risk Management (Yin Huang)
How to Establish An Effective Pharmacovigilance System to Ensure the Clinical Trial Risk-Benefit Assessments (Susan Soong)
 
The Questions of Subject Discussion
从The Emphasis Of Drug Risk/Benefit Considerations From The Different Roles Of Clinical Trial Institution, Investigator, Sponsor, CRO And Regulatory Agency, Etc..
How Is It Different onThe Drug Risk/Benefit Considerations In Different Periods( Period I to IV)
How Is It Different onThe Drug Risk/Benefit Considerations Between Investigator and Clinicians
Experts Attending the Session (In Alphabetical Order)
Ping Chen, director of Greater China Clinical Department, INC Research
Qin Huang, deputy minister of Biometrics Department, CDE
Yin Huang, the vice president of Pharmaceutical Division, CSPC Pharmaceutical Group Limited
WenlinGai, Senior Director of Clinical Department, Sinocelltech Ltd
Ji Jiang, Professor of Peking Union Medical College Hospital
Chunlei Li, President of Institute of Pharmaceutical Research, CSPC Pharmaceutical Group Limited
Shuting Li, Deputy Director of GCP Office and Secretary of IEC, Cancer Institute & Hospital, Chinese Academy of Medical Sciences
ZhiqiangNing, vice president of Shenzhen Chipscreen Biological Technology Co., LTD.
Yuankai Shi, vice president of Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Susan Soong, the CEO of Proswell Medical Company
Fenlai Tan, vice president of Zhejiang Beta Pharma
Qingli Wang, deputy minister of Pharmacology and Toxicology Department, CDE
Yinxiang Wang, the President of Zhejiang Beta Pharma
Sean Zhao, vice-president of Amylin Pharmaceuticals
Hongyang Zhang, Director of Jiangsu Hengrui Medicine Co., Ltd.
Kejian Zhang, deputy director of the South China Center for Innovative Pharmaceuticals