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3rd Annual Pharma Regulatory Affairs Asia Summit, China will be back in Beijing on 24 – 27 March 2015.

Event Overview

Obtain critical regulatory updates and gain access to China & East Asia’s market

IBC Asia’s Pharmaceutical Regulatory Summit Asia aims to deliver and clarify the latest regulatory updates in a complex Asian regulatory landscape. In addition, pharmaceutical safety and market access strategies will be discussed for efficient access to the China and East Asian pharmaceutical market.

This is the ONLY event which focuses on East Asian pharmaceutical regulations that offers both industry and authoritative professional’s critical regulatory updates and sharing of experiences, with a special focus on China’s pharmaceutical market.

会议概述

了解重大药物监管动态并获得进入中国和东亚市场的机会

IBC 亚洲的亚洲药物监管峰会的目标是在复杂的亚洲监管形势下提
供并阐明最新的监管动态。除此之外,还会讨论药物 安全 和市 场准 入战略,以便有效地进入中国和东亚医药市场。

这是唯一关 注东亚药物监管的会议,行业和权威专家将在该活动期
间提供重大监管最新动态并分享经验,并尤其针对中国医药市场。

Topics Covered at 2014 include
  • Key Regulatory Update from the National Institute for Food & Drug Control, Agency of the CFDA, China
  • A Wide Variety of Drug & Clinical Trial Approval Case Studies
  • Learn from Industry Best Practices on the Ground in China
  • Pharmaceutical Marketing Regulations & Compliance
  • Implementing Electronic Regulatory Affairs
  • Pediatric Investigational Plans (PIPs) & Development
  • Interactive & Open Discussion Session on Quality by Design (QbD)
  • Bridging studies and Waiver Opportunities
  • Drug-Device Combination Product Regulations & Development
2014 年的新课题
  • 中国食品药品监督管理局 (CFDA) 的关键监管动态
  • 关于药物和临床试验批准的广泛案例研究
  • 学习中国的行业最佳实践
  • 医药营销法规及合规
  • 实施电子监管事务
  • 儿科调查计划 (PIP) 与发展
  • 关于“质量源于设计”(QbD) 的互动和开放式讨论环节
  • 将案例与豁免机会进行衔接
  • 医药设备组合产品的法规和发展
Also not to be missed!

Pre-Conference Workshops (25 Mar 2014)

A: Preparing and Submitting Dossiers for Generic Drug Approval

B: Gaining Global Approvals of Biosimilars

Post-Conference Workshops (28 Mar 2014)

C: Regulatory Strategies for Emerging Market Access

D: Pediatric Drug Development

Speakers

Dr Jisu Kim
Director General
Korea Health Industry Development Institute (KHIDI) China
Prof. Ning Bao Ming
Deputy Director, Division of Chemical Drugs/GMP Inspector
National Institutes for Food and Drug Control, Agency of the CFDA, China
Stewart Geary
Vice President/Deputy Director, Corporate Regulatory Compliance & QA, Eisai Japan, Director
The Japanese Association of Pharmaceutical Medication
(JAPhMed), Japan
Annette Chiu
Regulatory &Medical Affairs Director, GlaxoSmithKlineChairperson of the Regulatory Affairs Committee
Hong Kong Association of the Pharmaceutical Industry
, Hong Kong
Dr Wu Ke
President
BravoBio, China
Dr John Z. Gong
Vice President of Drug Development and Regulatory Affairs
Beigene, China
May Wei
Global Regulatory Strategist
Bayer Healthcare, China
Dr Yamin Wang
Head, Global Regulatory Affairs, Asia Pacific
Bayer Healthcare Pharmaceuticals, Singapore
Amber Wang
Regulatory Affairs Manager
GlaxoSmithKline, Taiwan
Prof. Jack Wong
Director, Regulatory Affairs, Terumo BCT, Secretariat in Asian Harmonization Working Party (AHWP) and Founder of Asia Regulatory Professional Association (ARPA), Singapore

See Full Speaker Line Up, click here »

Why You Must Attend This Year’s Event
  • Ideal networking opportunities with regulatory representatives and industry experts
  • Develop strategies to gain market access into Asia
  • Develop cost-cutting strategies in getting drug approvals
  • Wide variety of topics covered including (but not limited to) CMC, Clinical trials, pharmaceutical marketing regulations, timelines
  • The ONLY event that has a China & East Asia focus: For an in-depth understanding of the region
  • Interactive sessions for you to influence and discuss on the various regulatory topics
Benefit from the closer interaction with regulators and networking opportunities with industry peers




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