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

Australia offers a compelling opportunity for clinical trials, with favorable regulatory framework, strong networks, excellent engagement with clinicians/researchers, and access to established and proven pathways of obtaining high-quality clinical data recognised by European and US regulators, and other global institutions. This speaking session will highlight how Australia’s clinical trials are a cornerstone for innovation and attractive environment for companies from around the world to develop their intellectual property.

As Europe positions itself as a leading destination for clinical research, the ability to deliver clinical trials at scale requires robust operational frameworks and strategic site management. This fireside chat explores what it takes to transform Europe into a thriving clinical trials hub, examining the critical operational elements that enable successful trial execution across diverse European markets.

• Assess the regulatory, infrastructure, and market factors positioning Europe as an attractive hub for clinical research

• Learn how to evaluate site capabilities and optimize performance using data-driven approaches tailored to Europe's diverse healthcare systems

• Understand best practices for streamlining study initiation processes, managing cross-border logistics, and accelerating timelines

• Discover how AI streamlines clinical trial operations- from intelligent protocol development and patient recruitment to digital twin technology that reduces patient requirements while maintaining regulatory compliance

• Learn strategies for shifting from traditional site-centric approaches to patient-focused trial designs that improve accessibility, diversity, and retention through decentralized and hybrid methodologies

• Explore real-world case studies and expert predictions on AI's future impact in precision medicine, regulatory evolution, and the transformation of clinical research operations