概览

Since the COVID-19 pandemic, the development of medical products based on the latest innovative technologies has accelerated, and the global pharmaceutical market is expanding rapidly. This has made regulatory science more important than ever.

The Korea Regulatory Science Center (KRSC) and DIA jointly organized a workshop entitled “Future Development Direction and Regulatory Science for Innovative Drugs”. With DIA-KRSC Workshop 2024 on September 26th in Seoul, immediately following the DIA Asia Meeting 2024, will provide you with a unique opportunity to discuss the regulatory perspectives and innovations first hand.

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The topics in each session:

Session 1: Global Regulatory Convergence - Current status and future directions of regulatory science for innovative medicines. Regulatory convergence and exchange of information on the regulatory framework and any proposed changes from US, Europe, and Asian countries.

Session 2: Management of Drug Safety during development and post-marketing pharmacovigilance.

Session 3: Regulatory science strategy for quality assurance of innovative new drug. In-depth quality control and safety assessment strategies for innovative new drugs.

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学习目标

Gain a comprehensive understanding of the latest innovations and changes in the biohealth sector, including medical product development
Get updates on global regulatory policies, review processes, and safety assessments for innovative new drugs
Get insight into the safety measures in place to protect people during the development and use of innovative medicines
Discuss the future of the regulatory science of medicines using cutting-edge technologies
Accelerating the development of innovative medicines through regulatory science collaborations

项目委员会

Yil-Seob Lee, MD, PhD Professor, Dept of Clinical Pharmacology
CHA Global clinical research center, CHA University, Korea, Republic of
In-sook Park Director General
Korean Regulatory Science Center, Korea, Republic of
Joon-Woo Bahn, MD Professor, Director
Asan Medical Center, Korea, Republic of
Deborah Chee Chief Executive Officer
Connect Clinical Sciences, Korea, Republic of
Youngju Choi, PhD Director General
National Institute of Food & Drug Safety (NIFDS), Korea, Republic of
Hyungjin Jung, MD Director
Johnson & Johnson Korea (J & J KR), Korea, Republic of
Younglim Kim, PhD Director General
National Institute of Food & Drug Safety (NIFDS), Korea, Republic of
Sora Lee Vice President, General Manager Korea
Syneos Health Inc., Korea, Republic of
Si-Nae Lee Director
Modona Korea, Korea, Republic of
Eui-Kyung Lee, PhD Professor
SKKU, Korea, Republic of
Misun Park, PhD Planning Director
Korea Regulatory Science Center, Korea, Republic of
Hyouyoung Rhim, MD, MSc Vice President
Yuhan Pharm inc., Korea, Republic of
Juyoung Shin, PharmD, MPH Professor
College of Pharmacy, Sungkyunkwan University, Korea, Republic of
Seung Young Song, BSN CRM
Janssen, Korea, Republic of
Hye Jong Yoo, MD
Astrazenca, Korea, Republic of
Shogo Nakamori, MBA, MSc, RPh Senior Vice President & Managing Director, DIA Japan, Korea, and Singapore
DIA, Japan