#25: Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China
Daniel Liu, PhD, MSc
- Chief Scientific Officer
- Beijing Clinical Service Center, China
20 years in the pharmaceutical industry in the management of global clinical trials. A core expert in the Steering Committee of State Clinical Data Standardization, CDE CFDA; Associate Director of CDM China; Professor at CFDA Inst of Executive Development; Writer- in- chief of "Clinical Trial Methodology of Medicinal Products"; Co-author for books: "GCP: A Q&A Reference Guide", "New Drug Approval Process", "Computerized Systems in Clinical Research: Current Quality and Data Integrity Concept".
Earl W. Hulihan, MEd
- SUTCM, United States
Professor Hulihan is Principal with ew hulihan and associates, inc. For over 35+ years, Hulihan has been active in the DIA, in Medicine, as well as providing regulatory consulting, auditing, and training services to the global pharmaceutical community and regulatory authority personnel worldwide.