Generic International Summit - Asia 2015 to Kick Off in May at Shanghai

Date： May 21-22, 2015

Venue：Bund East Shanghai Hotel, Shanghai China

Website: http://www.  

 

Generic Product Development is An Art of Science? Current Philosophy and Understanding in Light of Business Globalization

 

 

First thanks you trust and support on GIS Asia 2014.Under your support, it became a great success. Over 150 industrial leaders attended the conference and more than 90% participants are highly satisfied with the summit. This is a great encouragement inspires us to work hard and do better.

 

For GIS Asia 2015, in order to make the first class agenda, we invited Dr.Jack Aurora as our consultant. Many industrial leaders like Dr. David Zhao, Dr.Jianying Wang and Dr.Sven Stegemann gave us very valuable suggestions and supports. Doing all those things with only one purpose, we long to provide you the best platform for learning and communication and live up to your support and trust.

 

GIS Asia 2015 mainly covers four chapters, Business and Economics of Generics Growth, Formulation Design and Product Development, Analytical Methods and Stability Studies, and Regulatory and Management. Two day’s conference almost covers all the hot topics and key issues in the generic field. We also invited the first class experts from China and Oversea Countries to share their valuable insights and experience on strategy, technology and regulatory. I believe you who have a good eye for conference selection will find our uniqueness. We expect to meet you and other 200 industrial leaders in Shanghai on May 21-22.

  ► Explore and understand the already proven and tested optimal R&D strategies for developing generics and new drugs parallel

  ► Explore strategies for "first to file" submission to get approval for enjoying the market business

  ► Explanation of 180 generic drug exclusivity provisions and restrictions by the US FDA agency

  ► Next generation formulation design: Innovations in material selection and functionality and their role in product success

  ► Reformulation to the rescue: design and critical planning of performing characterization studies for a robust and strong formulation design

  ► Impurities control and setting specifications for various impurities including genotoxic and inorganic types

  ► Scale-up from lab scale to commercial scale equipment and process train? Practical design  and proven methods and applications will be discussed

  ► Dissolution method development: criteria and important considerations for successful product approval

  ► BE studies design and protocol development for different dosage forms and drugs

  ► Stability studies design and expectations for US and European drug submissions and approvals

  ► QbD development and practical implementation techniques for R&D professionals

  ► Practical experience shared for ANDA (generic) submission to US FDA for a quick and successful approval

  ► Practical solutions and skills development for a successful generic product submission and approval from CFDA agency

  ► Project management skills and practical approaches for success

  ► Marketing Authorization Applications (MAA) for Generic drugs in the European Union- general requirements and practical hints

 

Tianmin Zhu, Vice President of R&D, Hisun Pharmaceutical

Xiong Yu, Researcher, SIPI

Fred Xi, Vice President, USP

Axel Wenzel, CSO, EU Vigilance

Krishna Venkatesh, Vice President of Formulation, Dr.Reddy’s Laboratories

Paolo Biffignandi, CEO, VI.REL Pharma

Sven Stegemann, Director, Capsugel

Jun Han, CEO, SOTA International

Guojie Xu,Vice President of R&D, Visum Pharmaceutical

David Zhao, Senior Vice President, Prinbury Biopharm

 

Contact: Luke Xia,

T:+86-21-6053 8962

F: +86-21-6537 7300

E: luke.xia@bestmediaworld.com

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