2nd Pharma Regulatory Asia in Beijing

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With the growth and development of the biopharma industry and increasing changing legislations on areas like biosimilars, pediatric drug development and generic drugs in China and East Asia, now is the time for you to bring along your regulatory affairs teams to keep abreast of evolving regulatory environments and requirements at IBC’s 2nd Pharmaceutical Regulatory Summit in China. http://www.pharmaregulatoryasia.com/

Salud y medicina

14

25 – 28 March 20
g
The Westin Beijin
Chaoyang, China

East Asia
provals in China &
ug & Clinical Trial Ap
Accelerating Dr

What’s New in 2014?
Key Regulatory Update from the National
Institute for Food & Drug Control, China

Pediatric Investigational Plans (PIPs)

MORE Drug Regulations & Case Studies

Interactive & Open Discussion Session on
Quality by Design (QbD)

Electronic Regulatory Affairs
Learn from China Industry Best Practices

Discover Bridging Studies and Waiver
Opportunities

Pharmaceutical Marketing Regulations

Drug-Device Combination Products

2014 Regulatory Experts Include:

Prof. Ning Bao Ming

Annette Chiu

Stewart Geary

Deputy Director, Division of
Chemical Drugs/GMP
Inspector, National
Institute for Food and
Drug Control, Agency of
the CFDA, China

Regulatory & Medical Affairs
Director, GlaxoSmithKline,
Chairperson of the Regulatory
Affairs Committee,
Hong Kong Association
of the Pharmaceutical
Industry, Hong Kong

Vice President/Deputy Director, President,
Corporate Regulatory
BravoBio, China
Compliance & QA, Eisai Japan,
Director, The Japanese
Association of
Pharmaceutical Medication
(JAPhMed), Japan

Dr Wu Ke

May Wei
Global Regulatory Strategist,
Bayer Healthcare, China

PLUS! Informative Workshops on:
PRE-CONFERENCE WORKSHOPS • 25 MARCH 2014

POST-CONFERENCE WORKSHOPS • 28 MARCH 2014

A Preparing and Submitting Dossiers for Generic Drug Approval
B Gaining Global Approvals of Biosimilars

C Regulatory Strategies for Emerging Market Access
D Pediatric Drug Development

www.pharmaregulatoryasia.com
Produced by:

Supporting Organisation:

Media Partners:

Life
Sciences

International Marketing Partner:

REGISTER NOW! Customer Service Hotline: +65 6508 2401 / +86 21 2326 3680

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Why you should attend: 1. Learn from in-depth case studies on strategic partnering and effective collaboration 2. Explore new business opportunities and strategies to reach the biosimilars market in the region 3. Gain insights into the regulatory landscape for biosimilars in China, India, Korea, Taiwan and more 4. Gather the latest market intelligence and analysis and identify new trends and opportunities in Biosimilars R&D, contract manufacturing and commercialization in Asia 报名参加的五大理由 1. 深入学习有关与亚洲公司建立战略合作和有效协作的案例研究 2. 探索新的商机和战略，以便进入当地的生物仿制药市场 3. 深入了解中国、印度、韩国、台湾以及更多国家或地区的生物仿制药监管形势 4. 收集最新的市场情报和分析，确定生物仿制药研发、合同制造和商业化在亚洲的新趋势和机会 Hear about: Biopharma Regulatory Updates and Development Victoria Elegant, VP Medical & Regulatory Affairs, Baxter, China Andrea Laslop, Head of Scientific Office, Austrian Agency for Food and Health Safety, Austrian Member, European Medicines Agency Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals, Cadilla Pharmaceutical, India Advances in Biosimilars R&D Jeffrey Su, CSO, Cytovance Biologics, USA Wenzhi Tian, CEO, Huabo Biopharma, China Ming Wang, President and COO, Gan & Lee Pharmaceuticals, China Feng Li, CEO, Beijing Mabworks, China Shaligram Rane, Vice President for Quality, Intas Pharmaceuticals, India Understanding Obstacles and Hurdles for Entering the Biosimilars Market Khai Meng Ang, Vice President Asia, Hospira, China Jason Li, Senior Director, Genor Biopharma, China Sachidananda Moorthy, Vice President - Clinical Research, Medical and Regulatory Affairs, Avesthagen, India Sameer Agarwal, Senior Vice President, Business Center Strategic Marketing, Business Unit Generic Drugs & Standard Solutions, Fresenius Kabi, Germany What can Asia Learn from Global Biosimilars Development and Litigation? Li Cai, Regional R&D Counsel, Pfizer, China Vivek Mittal, Head – Legal, Lupin, India Viren Mahurkar, Managing Director, HitechnRock Advisors, Singapore http://www.biosimilarsasia.com Pre-Conference Special Focus Day, 20 May 2014 Clinical Development for Biosimilars Post-Conference Workshops, 23 May 2014 A: Challenges in Demonstrating Biosimilarity and Interchangeability of Biosimilar Products B: Successfully Bringing Biosimilars to Market 会前特别关注日，2014 年 5 月 20 日生物仿制药的临床开发会后研讨会，2014 年 5 月 23 日 A：在展示生物仿制药产品的生物相似性和可互换性方面所面临的挑战 B：成功地将生物仿制药推向市场

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