Archives: Agenda

• Current landscape and growth trends of clinical trials in Korea, especially for small/mid-sized biopharma
• Navigating the evolving vendor and CRO ecosystem as a small to mid-sized sponsor
• Regulatory environment and recent updates impacting trial initiation and approvals

• Highlight the evolution and major breakthroughs of AI in medical imaging over the past decade
• Real-World AI Applications and the New Era of Imaging Outsourcing in Clinical Trials
• Future trends and roadmap AI integration for radiology and imaging CROs

• Addressing regulatory uncertainties and evolving guidance for advanced therapies
• Building trial plans that embed real-world evidence and extended follow-up
• Implementing robust safety monitoring strategies for acute and long term risks

• Key considerations for planning and determining the suitability of DCTs
• Reviewing how DCTs can enhance trial reach and significantly boost patient recruitment
• Sharing practical insights and lessons learned from implementing DCTs

• Infrastructure Strengths of the UAE & GCC for Clinical Research
• UAE’s Precision Medicine and Genomics Ecosystem: A Global Benchmark
• Why the GCC is Emerging as the Next Global Hub for Clinical Trials

·       Expansion Support:  CROs guide Korean biotechs through regulations, operations, and global site access to move beyond domestic trials.

·       Asia Hub Model: With hubs in Korea and Taiwan, CROs like Avance Clinical offer turnkey infrastructure — entities, vendors, and site partnerships.

·       From Phase I to MRCTs: Linking Australia’s fast Phase I ecosystem with Asia’s Phase II/III scale accelerates global development.

• Regulatory landscape US: Pre-IND and IND
• Bridging APAC With US
• Current US administration / FDA – What are we seeing at QPS?