The 6th NEXTGEN CHINA 2016,Grasp Opportunity under Changeable Policy Environment and Fierce Competition

The 6th NEXTGEN CHINA 2016
April 12-13,New World Shanghai Hotel

2016 Conference Background

In the past 10 years, the market development growth of generics was twice as much as innovator drugs. In the next few years, there will be a drug patents expire peak. 1295 generic drugs will be off-patent during the year 2014 to 2018, which will affect $19.7 billion in total.
 – Data from Analysis report on production and marketing of chemical pharmaceutical industry in China during 2015-2020.

There are lot of policy and regulation updates in China according to CFDA measurement. The new policy will influence the whole generics industry chain in perspective of generics application, quality improvement, clinical data requirement and internationalization.

Based on the data analysis from CFDA that there are around 5,000 pharmaceutical manufacturers in China in total, and 90% of them manufacture generics. There will be big changes and great adjustment around the year of 2018 due to the changeable policy and market environment.

The 6th NEXTGEN CHINA 2016 will gather all resource of CPhI global and essence of past five conferences to explore topics above and showcase evolving generics landscape & solutions.

Conference Structure

Day One (April 12, 2016)	Chapter One: Regulation and Policy Discussion
	Chapter Two: Market and Competition
Day Two (April 13, 2016)	Chapter Three: R&D and Technology

Who Should Attend

Past Attendees

Teva, Mylan, Sandoz, Pfizer, GSK, Boehringer-Ingelheim, AstraZeneca, Sanofi, Movartis, Merck, JNJ, Abbott, Bristol-Myers Squibb, Bayer, Roche, Dr. Reddy’s, Shanghai Pharma Group, Huhai, Hengrui, Yangtze River, Tasly, China Resources, Xian-Janssen, Qilu, Zhejiang Medicine, Wuhan Humanwell, Northeast Pharm, North China Pharmaceutical, Sinopharm, Kelun Group…

>> Please refer to the whole list of past attendee including Name, Job title Company

2016 Agenda

Conference Day One
0830-0900	Registration & Networking
Chapter One: Regulation and Policy Discussion
0900-0910	Opening Remarks
0910-0950	Clarifying and solutions: generics consistency evaluation on quality and efficacy     Core content clarifying of generics consistency evaluation: selection of reference product and research method     Influence of policy updates on generics manufacturers     Market competition pattern changes due to the policy updates
0950-1030	Implementation and forecast: opportunities for generics manufacturers     Changes of bioequivalence test-shorten of development period     Updates of generics application process-speed up approvals     Forecast of the new policy implementation and the different market state
1030-1050	Tea Break
1050-1130	Drug Marketing Authorization Holder (MAH), feasibility analysis in China     Understanding content and essence of MAH     Positive impacts of MAH on generics R&D and innovation     Feasibility analysis of MAH implementation in China
1130-1200	Industrial consolidation under changeable policy environment, opportunities and challenges for CROs     Opportunities for CROs due to policy updates     More responsibilities for CROs based on clinical data inspection     How to cooperate with generics manufacturers for mutual benefits
1200-1240	Panel Discussion: Policy and regulation updates and the development of the whole generics industrial chain     Advantages and experience sharing from policy in US, EU and Japan     Supporting policies in clinical application, purchasing and bidding and medical-care system     Development bottleneck and trend for manufacturers, CROs, excipients suppliers and other industrial chain companies
1240-1400	Lunch
Chapter Two: Market and Competition
1400-1440	Analysis of the changing generics market in Chinese and overseas     Influence of generics quality consistency evaluation on market trend     Current situation and tendencies of Chinese generics market     Strategy adjustment like first generic drug and high-end generics
1440-1520	Strategic cooperation and M&A-how to seek for new chances for generics manufacturers     Current situation of capital operation in generics market     To realize value maximization through strategic cooperation, investment and M&A     Trend prediction of the whole generics industry
1520-1540	Tea Break
1540-1620	Export to US and EU market, bottleneck and opportunists for Chinese generics manufacturers     The requirement and policy environment in US     Problems for the export to US and EU market, and solutions exploration     How to break through bottlenecks to promote formulation export
1620-1700	International strategy discussion for Chinese generics     The gap and improvement of product R&D and quality     Marketing and brand strategy in overseas market     How to formulate the international strategy
Conference Day Two
0830-0900	Registration & Networking
Chapter Three: R&D and Technology
0900-0940	Intellectual property strategy in generics development process     Importance of IP protection for generics manufacturers     IP rights dispute in generics development process     How to reply the IP dispute to speed up project setting up and R&D
0940-1020	Innovative strategy and methods in generics R&D     Key points and strategy of project setting up     Key technology in generics R&D     Quality control approaches of generics
1020-1040	Tea Break
1040-1120	Standard of excipients and development for excipients suppliers     Exploring standard of excipients in 2015 pharmacopeia     Quality control of key excipients and the importance for formulation R&D     How to make improvement in perspective of key technology, product quality and service for excipient suppliers
1120-1220	Strategy of generics impurity control and the specific methods     Regulation requirement of impurity control in generics application     Impurity control in CMC research     Specific methods of generics impurity control
1220-1330	Lunch
1330-1410	Panel Discussion: Bioequivalence test or dissolution test in generics R&D?     Reference of related standard and research     Requirements of regulatory bodies and problems in product application process     Analysis of advantages and disadvantages of BE test and dissolution test
1410-1510	Testing and comparison of dissolution rate     Testing methods of multitier dissolution rate in innovative drug     Determine the parameter of quality standard     Key technologies in dissolution testing
1510-1530	Tea Break
1530-1700	Governing principles of BE testing and the specific practice     Exploring the principles of formulation BE testing     How to prepare the BE data and material     Resource analysis of BE testing and expansion methods     How to apply for BE for re-evaluation for listed product     How to confirm the authenticity and normativity of BE testing
17001710	Close Remarks

About Organizer

We serve 16 market sectors with wholly-owned subsidiary companies and JV companies in 10 offices in the major cities in mainland China, including Beijing, Shanghai, Guangzhou, Hangzhou, Guzhen and Shenzhen. We provide over 60 products and services in various categories: trade fairs, conferences, publications, websites and training. As China’s largest commercial exhibition organiser, we stage the leading events of their kind in China, most being the largest in Asia or second in the world. Our 53 exhibitions, 10 conferences, six publications and six vertical portals serve tens of thousands of exhibitors, visitors, conference delegates, advertisers, subscribers and corporations in the country and from all over the world with high value face-to-face business-matching events, quality conference programs presented by top-notch industry leaders, instant news on market and industry trends and round-the-clock online trading networks and sourcing platforms.

CPhI Conferences deliver the latest pharma market insight, in-depth case studies and exceptional networking opportunities through a programme of high-level conferences. The worldwide series of events, spanning four continents, provides the optimum forum for you to learn, make new business connections and identify the latest growth opportunities.

Hotel Info
Ballroom in 3F, New World Shanghai Hotel
Address: No. 1555 Dingxi Road, Changning District, Shanghai, China