Welcome to the 4^th Annual

China Clinical Trials Outsourcing Congress

17-18 September 2012

China’s huge population and the government’s commitment to health care are predicted to make the country the world’s second-largest consumer of pharmaceuticals by 2015. Whilst this has made China an increasingly popular location for outsourcing clinical trials to, obstacles such as the necessity of collecting clinical trial data on patients in China before the Chinese State Food and Drug Administration (SFDA) will approve a drug for sale in their country have meant that only 152 international, multi-centre clinical trials were initiated in China in 2010 representing just three percent of the total worldwide.

Steps taken by the Chinese government including the creation of a centralised SFDA which helped in decreasing the number of conflicting standards between central and local government’s have resulted in shorter approval times. However approval for to initiate a drug based clinical trial can still take up to 12 months which is several months longer than some other Asian Countries although this is offset by the time-line for the first patient enrolled. The Ethical Committee (the China equivalent for an IRB) approvals and hospital contracting, both normally take less than six weeks in total.

Further steps taken in the modernisation of the Chinese Drug industry has been investment of over $1 billion dollars by the SFDA to support research and development of new drugs in China as well as providing tax breaks for foreign companies for foreign companies. This will help to develop a new market that up till now has comprised 95% generic drugs.

The 4th China Clinical Trials Outsourcing Congress will address the operational, logistical and regulatory challenges of conducting clinical trials in China as well developing post approval markets within China.

Some of the topics under discussion will be –

Is there still a gap between the international and Chinese standards for conducting clinical trials?
What are the new opportunities / areas for clinical trials in China?
Getting approval for a clinical trial application is a time-consuming process in China. How does this affect the market and the players and what can be done to minimise this?
Do foreign CROs have an edge over local companies in China?
Conducting oncology clinical trials in China
Utilizing unique gene pools found in China to conduct pharmacogenomic studies
Understanding the challenges of site selection in China and how this will affect the outcome of clinical trials
The challenges and benefits of conducting clinical trials in tier 2 and 3 cities in China
How language and cultural barriers can be overcome
Patient recruitment challenges in China – a large treatment naïve population does not necessarily mean recruitment will be easier
Overcoming logistical barriers to conducting clinical trials in China – setting up the perfect supply chain
Requirements and considerations for commercialisation after successful trial completion