The China Clinical Trials Outsourcing Congress 2009

The pharmaceutical market has rapidly expanded over the past years to become truly global including the R&D sector. An increasing trend is to use so-called emerging markets where clinical trials can cost substantially less than those in Western countries.

China is at the forefront of this trend. The country has a well established tradition of developing medicines from basic research and the demand for modern pharmaceuticals is growing. Foreign companies are now realizing that these factors are of direct benefit for the conduct of clinical trials as they seek to alleviate the escalating time and costs of drug development.

However, the decision to outsource clinical trials to China requires an understanding of the scientific and regulatory changes in China and knowledge of Chinese culture in order to establish strong business relationships to ensure that patients, investigators and research staff carry out clinical trials according to ICH and GCP.

The China Clinical Trials Outsourcing Congress will address the major issues involved with commencing clinical trials in China. Some of the topics under discussion will be:

• Incorporating China into your clinical trial strategy

• Strategic and Regulatory considerations before conducting clinical trials in China

• Considerations involved in designing the China component of the trial to position the drug for eventual China market approval

• Assessing the real value of incorporating China into a multinational clinical trial strategy

• The China SFDA has been working more closely with regulatory bodies and global industry leaders to improve its processes and approval times. Is this still an obstacle and will it bring about change in the near future?