概览
This Asia meeting 2024 will bring together industry, regulatory authorities, and academia to address pressing challenges in public health and drug development in Asia. The event will feature sessions where speakers will discuss recent advancements in regulatory science and the use of innovative tools to expedite clinical development and pharmacovigilance (PV).
One key topic will focus on regulatory agencies’ perspectives, highlighting recent advances in regulatory science and how the medical and regulatory landscapes are evolving. Speakers will also explore areas ripe for innovation in regulatory science.
Another topic will delve into the impact of real-world data (RWD) on regulatory decision-making, featuring case studies showcasing RWD’s role in indication expansion, new drug approvals, and post-marketing studies. Speakers will assess data quality, integration, analysis methods, and practical considerations.
Additionally, experts from the pharmaceutical industry will discuss the latest developments and practical applications of AI in clinical development. Topics will include indication selection, patient enrichment, AI-supported diagnosis, operational excellence, and AI-powered medical writing.
Lastly, This event will explore the integration of AI technologies in safety surveillance, signal detection, and risk management in pharmaceuticals. Attendees will gain insights into leveraging AI for enhanced patient safety outcomes through collaboration and knowledge-sharing.
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项目委员会
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Yil-Seob Lee, MD, PhD Professor, Dept of Clinical Pharmacology
CHA Global clinical research center, CHA University, Korea, Republic of -
Hironobu Saito, PhD Specially Appointed Professor
Tottori University, Chromosome Egineering Research Center, Japan -
Xiaojun (Wendy) Yan, MD, MBA Senior Vice President, Senior Advisor
BeiGene (Beijing) Co., Ltd., China -
Jing Ping Yeo, PhD Global Head, Project Operations & Head, Transformation
George Clinical, Singapore -
Xiaoyuan Chen, PhD Director, GCP Officer
Beijing Tsinghua Changgung Hospital, China -
Youngju Choi, PhD Director General
National Institute of Food & Drug Safety (NIFDS), Korea, Republic of -
Fengyun (Vicky) Han Senior Director, Head of Regulatory Policy for Asia Pacific
Johnson & Johnson Pte. Ltd., Singapore -
Qiang Li
Servier (Beijing) Pharmaceutical R&D co.ltd, China -
MinJung Lim, MPharm Managing director
MediSafe, Pharmacovigilance Services, Korea, Republic of -
Jessica Liu, MD VP, Head of Merges and Acquisition Management Department
Tigermed Consulting Co., Ltd, China -
Atsushi Ogawa
ICON Japan K.K., Japan -
In-sook Park Director General
Korean 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 -
Shun Jin, MBA Head, Regulatory Affairs, APMA
Sandoz Asia Pacific Pharmaceutical Pte., Ltd., Singapore -
Danny Soon Chief Executive Officer, CRIS, Executive Director, SCRI, Interim Executive
Director, ACTRIS, Singapore -
Yuji Kumagai, MD, PhD Professor, Kitasato Clinical Research Center
Kitasato University Hospital, Japan -
Yoshiaki Uyama, PhD, RPh Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Jun (Catherine) Xie Sr. Manager of Safety Assessment
Pfizer (China) Research and Development Co., Ltd., China -
Kum Cheun Wong, PharmD Head Asia Pacific Regulatory & Development Policy
Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore -
Shogo Nakamori, MBA, MSc, RPh Senior Vice President & Managing Director, DIA Japan, Korea, and Singapore
DIA, Japan -
Young Joo Park VP, Korea, Singapore, and Southeast Asia
DIA, Korea, Republic of