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Clinical Trials and Drug Development

Session 1: Innovations in Clinical Trial Design

  • Adaptive clinical trial designs and Bayesian methods
  • Patient-centered Endpoints and Outcomes in clinical research
  • Virtual and decentralized trials: opportunities and challenges
  • Real-world Evidence and its Role in clinical trial design

Session 2: Drug Discovery and Development: From Bench to Bedside

  • Target identification and validation in drug discovery
  • High-throughput screening and combinatorial chemistry
  • Preclinical Models and Their Role in drug development
  • Translational research: bridging the gap between basic science and clinical applications

Session 3: Regulatory Landscape and Drug Approval Processes

  • Regulatory considerations in clinical trials: FDA, EMA, and other agencies
  • Accelerated Pathways for drug approval
  • Post-marketing surveillance and pharmacovigilance
  • Harmonization and global regulatory frameworks

Session 4: Pharmacoeconomics and Market Access

  • Health technology assessment in drug reimbursement decisions
  • Value-based pricing and innovative pricing models
  • Market access strategies for novel therapies
  • Patient access to investigational drugs and compassionate use programs

Session 5: Precision Medicine and Personalized Therapies

  • Biomarkers and companion diagnostics in precision medicine
  • Gene and cell therapies: recent breakthroughs and challenges
  • Immunotherapies and their Impact on cancer treatment
  • Patient engagement in clinical trials and personalized medicine