New Drug Development Environment in China


Driven by policies, technological development, and the market, the biopharmaceutical industry has grown rapidly in recent years. As the new drug development ecosystem takes root in China, the region has become a key player in global drug development.

This module will focus on analyzing the current environment and new trends of drug development in China, covering the analysis of regulation development directions, the interpretation of the latest guideline for clinical trials, the selection of control drugs for MRCT, and the characteristics and application of DCT. This workshop will help clinical research professionals gain key insights into the drug development trends in China and empower decision makers to optimize their strategy.

Workshop Outline

  • Analyzing emerging trends in regulations
  • Regulatory requirements from the new guidelines in trending areas (e.g., oncology drugs)
  • Communicating with regulatory agencies
  • Phases I to IV clinical research guidelines under the newest regulations
  • Clinical value-oriented and patient-centered new drug development
  • Post-marketing research
  • Selection of control drugs for Multi-Regional Clinical Trial (MRCT)
  • Understanding Decentralized Clinical Trials (DCTs)
程序 | Global Clinical Development Strategy Workshop Series