The 2^nd China Clinical Trials Outsourcing Congress will feature two streams with a comprehensive and in depth programme of keynote addresses and case study presentations delivered by over 30 senior level industry speakers from China and across the globe. Some of the key topics under discussion will be –

Stream 1 – Preclinical Studies

Current state of preclinical study services in China. What are the current and on going steps be taken for compliance with Western GLP standards

Cultural, language, training and operational issues that impact on evaluating and managing preclinical studies using a China – based CRO

Case studies of Western companies with and without operations in China who have been successful in conducting preclinical trials in China

Considerations for study sponsors before committing to a Chinese CRO and gaining acceptance of preclinical data by FDA and EU regulators

Best structure for preclinical studies in China – ensuring IP protection, CRO ownership and laboratory animal rights regulations are met

Advantages for companies considering NHP studies in China

Import procedures for investigational drugs

Stream 2 - Clinical Trials

A general overview of the Chinese healthcare system

Evaluating development options available based on regulatory and market considerations

A review of the China CRO industry – using Chinese CROs against building an operation in China

New initiatives currently being introduced by the SFDA – a review of the regulatory agencies in China and the direction they are taking

A look into the future of clinical trials in China

The role of academic clinical research organisation partnerships in China and the benefits for sponsors

Challenges of ensuring quality when conducting large scale clinical trials in China

Patient recruitment and retention in China

Electronic Data Management in China

Clinical Data Management in China

Evaluating logistical challenges and procedures to ensure compliance with regulatory procedures

If would like to present on any of the above topics or would like to contribute other presentations or case studies please contact me – Steve Hambrook at steve@globalengage.co.uk or telephone +44 (0) 1865 811 189.