Date: July 31 – August 2nd , 2025 (THU-SAT) 

Time: 9:00 AM – 5:00 PM

Address: The University of Hongkong 

Language of Instruction: English 

Developed by Clinical Development & Regulatory Innovation International LLC, USA 

Jointly Organized by DIA China and The University of Hong Kong Clinical Trials Centre

A Case-Based Interactive Course on Science and Art in  Regulatory Decision-Making

Course Description:

This 3-day intensive course transcends traditional lectures by immersing participants in  practical, real-world regulatory challenges. Key concepts are brought to life through case  discussions and role-playing of actual U.S. FDA decisions, based on a real drug product  that was approved, withdrawn, and reintroduced in the US market. This case is a landmark  example of how the FDA balances safety, efficacy, and patient access in high-risk  therapies. 

At its core, this course emphasizes the science, leadership, teamwork, and  communication necessary for complex regulatory decision-making under uncertainty. It  also focuses on discovery and insights over traditional knowledge acquisition. Participants  will engage in case-based learning and role-playing to enhance their skills. 

Participants will engage in dynamic case discussions, and role-playing that provide a  practical, in-depth understanding of: 

1. Key Concepts in Context: The science of efficacy and safety determinations  within risk-benefit assessment, patient-centered evaluation, and decision-making frameworks brought to life through case analysis.

2. Leadership in Action: Navigating the multifaceted challenges of regulatory  decisions with a focus on balancing evidence, ethical considerations and  competing interests of different stakeholders.

3. Communication with Impact: Developing the skills to present and defend risk benefit decisions to diverse stakeholders, including agency leadership, industry,  healthcare providers, and the public. 4. Role-Playing of Real FDA Decisions: Participants will practice making and  justifying decisions regarding drug approvals and market withdrawals.

Course Instructors

ZILI LI, MD MPH, is a globally recognized expert in drug risk-benefit assessment. His notable contributions include co-authoring two FDA guidance documents on risk assessment and management and receiving FDA Scientific Achievement Award for his work in risk benefit assessment. Dr. Li has extensive experience in drug risk-benefit assessment as a medical reviewer and team leader at FDA, and in his leadership role in directing the assessment at pharmaceutical industry, including as the vice president at Johnson & Johnson.

Dr. LI was the co-chair and co-founder of US FDA Alumni Association International Network, having develop and delivered educational course in drug risk benefit assessment for China FDA, Korea FDA and Taiwan FDA. He received special recognition awards from the Commissioner of US FDA for his work. He also was principal instructor for American Course on Drug Development and Regulatory Sciences (ACDRS) at UCSF and the Chair for Drug Risk and Benefit Assessment Course at Yeehong Business School in China.

Dr. LI, a graduate of Peking Union Medical College and licensed physican, completed his medical residency training at Johns Hopkins. Zili also holds a master's degree in public health from the Johns Hopkins University School of Public Health.

MENGJUAN LI, a seasoned HR leader, specializes in talent development and capacity building in the pharmaceutical industry. Her expertise spans organizational transformation, cross-cultural leadership, and talent pipeline development, making her a key contributor to building high-performance teams.

Over her career spanning more than 30 years, she has spent a third of her time managing large teams in overseas markets such as the United States, Japan, and Singapore, successfully leading organizational transformations.

Ms. LI, is currently the chairperson for DIA China Advisory Committee on Global Talent Development and International Exchange, and frequent speakers and lecturers on talent development and global mindset for many domestic and international conferences and/or executive or degree programs in the universities.

Agenda

More about the Course: 

Briefing  -  Training Guide.pdf

Contact DIA

Email: china@diaglobal.org

About DIA

DIA (Drug Information Association) is a global, interdisciplinary scientific platform that operates in a neutral environment. It brings together thought leaders from across the pharmaceutical R&D to discuss current scientific and technical issues, enhance professional capabilities, and catalyze industry consensus. DIA enjoys a high reputation in the global pharmaceutical R&D community for its commitment to advancing research and development efforts and fostering innovation.