Overview

DIA Korea Annual Meeting 2025, under the theme “Learn and Work: Accelerating Innovative Pharmaceutical Development and Advancing Regulatory Reliance,” holds significant meaning from both clinical development and regulatory science perspectives. In an era of rapid technological advancements and growing healthcare needs, innovative approaches in clinical development are essential to deliver safe and effective therapies to patients faster. This event will serve as a crucial platform to discuss cutting-edge strategies, novel methodologies, and emerging trends that can enhance the efficiency, quality, and success of clinical trials.
From the perspective of regulatory science, DIA Korea Annual Meeting 2025 highlights the importance of fostering regulatory reliance to streamline approval processes and reduce duplication of effort across regions. Regulatory reliance encourages collaboration and mutual trust among global regulatory authorities, enabling faster decision-making and facilitating patients’ timely access to innovative medicines. It is an essential strategy for harmonizing global regulatory standards while addressing local and international healthcare challenges.
The joint workshop on the second day, co-hosted by NIFDS (National Institute of Food and Drug Safety), DIA, and KRSC (Korea Regulatory Science Center), carries significant importance. This workshop demonstrates a unified effort to bridge gaps between regulators, industry professionals, and research organizations. By encouraging open dialogue and shared expertise, it aims to address key challenges in regulatory science, such as enhancing approval efficiency, aligning standards, and ensuring bio-pharmaceutical quality and safety.
This collaborative approach is critical for advancing regulatory frameworks that can support innovation while maintaining high standards of safety and efficacy. The workshop will foster mutual learning, encourage the adoption of best practices, and strengthen Korea’s role as a leader in the global bio-pharmaceutical regulatory landscape. DIA Korea Annual Meeting 2025, with its focus on innovation and cooperation, is poised to accelerate clinical development and advance regulatory reliance, benefiting patients and stakeholders in Korea and Asia.

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Learn and Work ‘Accelerating Innovative Pharmaceutical Development and Advancing Regulatory Reliance’.

Day1
Keynote speech : Needs for New Treatment Modality for Unmet Medical Needs
Session 1. Trends and Hot Topics in CGT Development
Session 2. Patient Diversity, Equity and Inclusion in Clinical Trials and Regulatory Insights
Session 3. Can RWE Replace Conventional Clinical Trials in Regulatory Decision-Making?
Session 4. Drug Development with Innovative Technology
Session 5. Challenges and Opportunities for the Environmental Changes in Clinical Trials
Day2
Plenary speech : WHO, Regulatory Reliance
Session 6. International Regulatory Collaborative Frameworks based on Regulatory Reliance
Session 7. Transforming Regulatory Science: Global Trends and Innovative Technology Applications
Session 8. DTC : Improving Patient Access to Clinical Trials through Decentralization
Session 9. Risk Communication Strategy for Patient Safety
Session 10. CMC and non-clinical data: What is the gap for the Success in IND and NDA/BLA? How Can We Ensure Success?

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Program Committee

Yil-Seob Lee, MD, PhD Professor
CHA Bundang Medical Center , Korea, Republic of
Joon-woo Bahn, MD, PhD Professor
Asan Medical Center, Department of Convergence Medicine,, Korea, Republic of
Hye Ryun Esther Bahng, MSc Director
Market Access & Regulatory Affairs, Astrazeneca, Korea, Republic of
Deborah Chee, MD, PhD, MBA Partner
Gateway Sciences , Korea, Republic of
Youngju Choi, PhD Director General
National Institute of Food & Drug Safety (NIFDS), Korea, Republic of
Hyungjin Jung, MD, MBA Senior Director
Johnson & Johnson Korea (J & J KR), Korea, Republic of
Juhye Kang, PhD Director General
MFDS, NIFDS, Korea, Republic of
Hojeong Kim, PhD
Ministry of Food and Drug Safety, Korea, Republic of
So Hee Kim, PhD Director / Ministry of Food and Drug Safety
National Institute of Food and Drug Safety Evaluation (NIFDS), Korea, Republic of
Sora Lee, MBA, MPharm, RPh Vice President, General Manager Korea
Syneos Health Inc., Korea, Republic of
Dae-Hee Lee, MD, MS President
The Korean Society of Pharmaceutical Medicine , Korea, Republic of
Won Sik Lee, MD, PhD CEO
Idience, Korea, Republic of
Min-Jung Lim, MPharm, RPh CEO & Senior Pharmacovigilance Consultant
MediSafe, Pharmacovigilance Services, Korea, Republic of
Yunni Lim, RPh Clinical Operations Portfolio Leader / President, KCDA
Roche Korea Co Ltd, Korea, Republic of
Dong Hee Na, PhD Professor
Chung-Ang University, Korea, Republic of
Kyuho Oh Vice President
KCRO Association, Korea, Republic of
Hyesook Park Head, General Manager
CMIC Korea, Korea, Republic of
In-sook Park, PhD Director General
Korean Regulatory Science Center, Korea, Republic of
Misun Park, PhD Planning Director
Korea Regulatory Science Center, Korea, Republic of
Judy Shin, PhD Professor
Korea School of Pharmacy, Sungkyunkwan University, Korea, Republic of
HaeSun Suh, PhD, MA, MPharm, RPh Professor, College of Pharmacy
Kyung Hee University, Korea, Republic of
Seung-In Um, PhD Vice President
Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea, Republic of
Hye Jong Yoo, RPh Executive Director
AstraZeneca , Korea, Republic of
Kyung-Sang Yu, MD, PhD, MBA Professor, Department of Clinical Pharmacology,
Seoul National University , Korea, Republic of
Young Joo Park, PhD, MPH VP, Korea, Singapore, and Southeast Asia
DIA, Korea, Republic of