China FDA (CFDA), now renamed as CNDA, made a series of significant changes to the clinical trial regulations, issuing a large number of guidelines and opinions in Chinese.
As an important stage during medical products development, the regulation in terms of clinical trial in China is experiencing the huge change, reviewing the Clinical trial application (CTA) is no longer like before, which the standard and requirement was much similar to a marketing authorization application.
Why should you Attend: Running clinical trials in China has become much easier. This is a highly attractive market for foreign companies, which has just become even more attractive. Opportunities and pitfalls abound.
Areas Covered in the Session:
The new CTA process
Timelines, requirements and relevant strategies
Comparison with the previous regulations
Communication strategies with the regulatory authorities
Links to the new regulations and guidances
Who Will Benefit:
Clinical Trial Managers
Regulatory Affairs Professionals
Yingying Liu is a senior consultant working for Michor Consulting. She is an experienced Regulatory Affairs professional with a background in pharmaceutical science and technology. Yingying has worked on local and global projects for various blue-chip healthcare companies in China.