Yi-Ling Tsai

Assistant Professor
National Taipei University of Nursing and Health Sciences

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Dr. Tsai is an Assistant Professor at National Taipei University of Nursing and Health Sciences, holding multidisciplinary academic backgrounds in pharmacy, business management, and health technology assessment. Her professional experience spans clinical practice, industry, and academia. She began her career as a hospital pharmacist, followed by more than a decade in multinational pharmaceutical companies from the US, Japan, and Europe. During this period, she held senior positions in sales, market access, and government affairs, gaining extensive expertise in generics, biosimilars, innovative drugs (including small molecules and biologics), and next-generation cancer genomic testing.
 
Dr. Tsai is proficient in healthcare reimbursement policies, pricing strategies, patient engagement and advocacy, value assessment frameworks, regulatory aspects of genomic testing, and health technology assessment. Her capabilities also include strategic planning, product lifecycle management, long-term care, regulatory affairs, and hospital management. Currently, her research primarily focuses on pharmaceutical policy, health technology assessment, and healthcare industry management. Dr. Tsai uniquely integrates clinical experience, industrial insights, and academic knowledge, providing valuable interdisciplinary perspectives in healthcare sciences and business management.

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Speech title & Synopsis

Insights from RAPS 2024: Advancing Global Harmonization, Convergence, and Reliance

As regulatory collaboration becomes an essential strategy for ensuring timely access to safe and effective medicines, concepts like harmonization, convergence, and reliance are increasingly shaping global pharmaceutical governance. This presentation shares key insights from the 2024 RAPS Annual Meeting, highlighting how international regulatory authorities—including EMA, FDA, WHO, and others—are implementing collaborative models to streamline regulatory processes, reduce duplication, and promote mutual trust.
 
Drawing on case studies such as the EMA–FDA Parallel Scientific Advice program, WHO’s Collaborative Registration Procedure (CRP), and EMA’s OPEN initiative, the talk will explore practical mechanisms that support regulatory alignment and shared assessments. In addition, the role of benchmarking tools, such as the WHO Global Benchmarking Tool (GBT), will be introduced as frameworks for evaluating regulatory system maturity and performance.
 
The latter part of the presentation will consider how these global trends may relate to Taiwan’s regulatory environment. Reflections will focus on the opportunities and challenges of aligning with international practices, and how Taiwan might further engage in global initiatives to enhance its regulatory visibility and efficiency. The session aims to stimulate dialogue on potential pathways forward, grounded in the evolving landscape of international cooperation in drug regulation.