概览
Online Registration has been closed.
Onsite Registration will be available at the venue from 9:00-9:30 on March 26 and 27, 2018.
To deliver drugs to patients with unmet medical needs as soon as possible, regulatory agencies must strengthen their review systems and shorten their review periods. Introducing expedited review systems, for example, will accelerate the development and delivery of new drugs from the regulatory side. R&D into new drugs by both companies and academia incorporate the latest science but still face challenges in addressing these unmet medical needs. Surrounding all this effort from industry, government and academia, the global development environment is also rapidly evolving day by day; grasping the impact of this evolution has become an important foundation for successfully meeting this challenge.
DIA’s 12th Asia New Drug Conference will share information on current and anticipated steps to collaboratively move forward. These include already established accelerated review pathways as well as progress and implementation of the ICH E17 guideline for planning and designing multiregional clinical trials, which will be specifically addressed by an expert panel followed by mutual discussion between our audience and speakers.
Experts from pharmaceutical companies and regulatory agencies will also provide the latest information about industry and regulatory challenges and initiatives, including next steps and how to proceed with tasks, in each Asian country. Topics related to risk and labeling management in various medical and regulatory environments have been prominently discussed in each country, and this conference provides a forum to further discuss these topics. We will also examine the remarkable change and recent regulatory reform introduced by the China FDA. DIA’s 12th DIA Asia New Drug Conference presents an opportunity for you to discover and consider new approaches for drug development in Asia. Now is the time for us to rise to meet this challenge. Now is the time for you to participate.
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项目委员会
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Yoshikazu Hayashi Associate Center Director (for New Drug Review)
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Ari Fujishiro Senior Director, Regulatory Affairs Group, Asia Development Dept., R&D Division
Daiichi Sankyo Co., Ltd., Japan -
Yoko Aoi, PHD Coordination Director - Office of Review Management
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Tomohisa Hayakawa, PHD Corporate Officer; Head of BD & PM
EPS International Holdings Co., Ltd., Japan -
In-Jin Jang, MD, PHD Professor
College of Medicine, Seoul National University, Korea, Republic of -
Shun Jin, MBA Head – BD & RA
PharmaGend Global Medical Services Pte Ltd, Singapore -
Rie Matsui, RPH Senior Director, Regional Labeling Head for APAC
Pfizer R&D Japan G.K., Japan -
Kosuke Mitsui, MBA, MSC, PMP President & General Manager
Chugai Pharma Science (Beijing) Co., Ltd., China -
Tosei Murase, PHD Associate Manager, Japan-Asia Clinical Development 1, Development
Astellas Pharma Inc., Japan -
Ryuji Nagata, PHD Consultant, Regenerative Medicine Promotion Office
EPS Corporation, Japan -
Shigeru Nakaji, MSC Vice President, RD Opearations, CRDO Office
Astellas Pharma Inc., Japan -
Atsushi Nonogaki, MSC Manager, Regulatory Affairs Group, Asia Development Department, R&D Division
Daiichi Sankyo Co., Ltd., Japan -
Ling Su, PHD Research Fellow
Yeehong Business School, China -
Crystal Wang Director of Development Division
Chugai Pharma Taiwan Ltd., Chinese Taipei -
Yoshiaki Uyama, PHD, MS, RPH Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
