Phacilitate Leaders Forum

17th - 18th SEPTEMBER 2019


Phacilitate Leaders Europe Agenda 2018


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
Business development and fund raising with Chinese potential partners and investors (5 min)
  • Real thinking forward combining experts in the field from manufacturing, regulatory and value vision” – “great network with strong experience and sharing risks & opportunities
    Jean-Philippe Combal
    GenSight Biologics
  • The conference consistently proves to be a great forum for networking with industry leaders in the development of cellular and gene therapies as well as vendors for important technologies and services.
    Michael Covington
    Juno Therapeutics, Inc
  • It was a very interesting event as all participants, including speakers were ready to exchange, even on the most challenging subjects such as reimbursement, GMP guidance
    Bertrand Alexandre
  • Phacilitate EU delivered it's promise and more, the topics discussed were highly relevant, with very good and professional speakers and panelists. You will see me next year in Berlin.
    Dr Ohad Karnieli
    Karnieli Ltd