CFDA pre-IND meeting preparation and IND submission in China for cell and gene therapy
12 Sep 2018
- Exploring China: Is there an opportunity in this region? Gap analysis of project readiness for landing in China
- Regulatory history
- Regulatory policies for RMAT
- Project in-house due diligence test for gap analysis
- China IND strategy
- How do we include China IND in the global picture of cell and gene therapy development?
- GMP! GMP! GMP! The myth of transferring GMP bioprocess in China
- China GMP vs EU GMP vs US GMP
- Domestic CDMOs regional distributions and by expertise area
- Can I ship Lentiviral Vector from EU/US to China for manufacture?
- Can I ship donor PBMC from EU/US to China for manufacture?
- Who should I contact and get approval for the cross board shipping approval in China?
- What documents should I provide for China IND preparation and to who?
- How to ensure clinical trial’s conducted in China are full GCP compliant? (10 min)
- China KOLs with RMAT experience
- China regulatory guidelines on GCP and RMAT related safety monitoring
- China CROs for domestic clinical monitoring
- How to find the best matching Primary Investigator and clinical site
- Site training
- Trial Master File document managements
- Data management and statistical analysis
- Regulatory submission and review process (10 min)
- CTD vs 31 documents standard
- Pre-IND meeting with CFDA CDE
- IND submission and review