Agenda for Day 2 - Tuesday 10 November, 2026Tuesday, 10 November 2026

Have you ever wondered what the future holds for clinical operations? More importantly, how can we prepare for what lies ahead? This session gives the audience a glimpse into the future by exploring the challenges to come and recommending solutions to implement now, in preparation for tomorrow.

• Explore how AI and global expansion are reshaping clinical trials, unlocking innovation and transforming operational efficiency across international markets

• Discuss the role of community engagement in driving operational excellence, fostering trust and improving patient participation and retention

• Identify disruptive pathways to accelerate trial timelines and navigate the evolving landscape of decentralised trials, patient diversity and digitalization

• Understand how to leverage China’s speed, patient access and regulatory flexibility to accelerate global development timelines

• Explore the surge in licensing agreements between global pharma and Chinese innovators and what makes China attractive for global partnerships

• Understand the regulatory evolution in the regional and their impact on development

• Examine cost-benefit frameworks for bridging studies across Japan, Korea, Taiwan and ASEAN countries, balancing regulatory requirements, ethnic sensitivity considerations and commercial ROI to accelerate regional approvals

• Explore the unique regulatory pathways and requirements across key Asian markets, including PMDA (Japan), MFDS (Korea), TFDA (Taiwan) and emerging frameworks in Southeast Asian nations

• Discuss proven strategies for managing multi-country trials in the region, including site selection and engagement in mature and emerging markets, patient recruitment in heterogeneous populations and building sustainable partnerships with local CROs and research institutions

• Future-Proof emerging opportunities across Southeast Asia's growing clinical trial ecosystem, the rise of decentralized and hybrid trial models adapted to Asian healthcare systems and how to leverage real-world evidence and digital health innovations tailored to local market needs

• Address unique regulatory hurdles and innovative approval pathways for rare disease clinical trials, including adaptive designs and strategies for generating robust evidence with limited patient populations

• Examine the impact of political and leadership changes at the FDA and across global regulatory agencies, and how these shifts influence drug development priorities, review timelines, and enforcement approaches

• Align trial design with evolving regulatory requirements by incorporating real-world evidence, digital endpoints, and quality-by-design principles that strengthen submissions and accelerate approvals

• Discuss Australia’s unique position as a global clinical trial hub

• Examine regulatory advantages, patient recruitment strategies and cost efficiencies

• Explore operational excellence in Australia’s clinical trial landscape

• Learn how to assess site feasibility and optimize performance using data-driven approaches

• Discover strategies for expanding trial footprints into diverse and underserved regions

• Understand best practices for streamlining study start-up processes and managing logistics effectively

• Explore innovative solutions, including decentralized clinical trials, to enhance trial success

• Highlight opportunities in Eastern Europe, MENA and medium- to low-income countries

• Explore the role of local partnerships in accelerating trial timelines

• Address infrastructure and resource challenges in emerging markets