アジェンダ
10:00 AM — 12:00 PM
ICH E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials10:00 AM — 12:30 PM
M8: Regulatory Operations Management in CTD/eCTD Submission1:30 PM — 5:45 PM
Data and Data Standard Management under ICH-GCP Guideline8:30 AM — 12:00 PM
Adaptive Design & Enrichment Design8:30 AM — 12:00 PM
RWE to Support Regulatory Decision Making10:30 AM — 12:00 PM
Biopharmaceutical Continuous Manufacturing2:00 PM — 5:00 PM
OPENING PLENARY8:30 AM — 10:00 AM
Consideration for the Safety of Clinical Research & Development Plan8:30 AM — 10:00 AM
Current State and Pain Points of Drug Research and Development in China8:30 AM — 10:00 AM
Digital Technology to Advance Drug Supervision and Patient Access8:30 AM — 10:00 AM
RWE Design and Case Study10:30 AM — 12:00 PM
Challenges in Safety Assessment of Tumor Immunity10:30 AM — 12:00 PM
Development of Innovative Therapy for Liver Diseases10:30 AM — 12:00 PM
Medical Writing Evolution in the New Era10:30 AM — 12:00 PM
New Technologies and New Targets for Immuno-oncology10:30 AM — 12:00 PM
Risk-based Pre-Approval Inspection1:30 PM — 3:00 PM
Decentralized Clinical Trials: from Nice-to-have to Must-have1:30 PM — 3:00 PM
Overcoming Challenges in Orphan Drug Development1:30 PM — 5:00 PM
Strategy for Early-stage Research and Development of siRNA and ADCs3:30 PM — 5:00 PM
Application of Blockchain and Computing Technology in Clinical Study3:30 PM — 5:00 PM
Early Phase Adaptive Designs3:30 PM — 5:00 PM
eSource and Digital Data Management3:30 PM — 5:00 PM
Subject Protection Work under Public Health Emergencies8:30 AM — 10:00 AM
Lifecycle Registration Change Management8:30 AM — 10:00 AM
New Technology for Gene/Cell Therapy8:30 AM — 10:00 AM
Real World Data (RWD) Management and Application in Clinical Research8:30 AM — 10:00 AM
Remote Intelligent Clinical Trials10:30 AM — 12:00 PM
Application of Digital Technology in Clinical Trials10:30 AM — 12:00 PM
Expedited Regulatory Pathways: Speed vs. Haste10:30 AM — 12:00 PM
Regulations and Practices of Clinical Data Submission10:30 AM — 12:00 PM
Regulatory Environment for Registration of Gene/Cell Products