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    Upcoming Event: Generic International Summit - Asia 2015 3/18/2015
    Event: Generic International Summit - Asia 2015
    Dates: May 21 - 22, 2015
    Venue: Wyndham Bund East Shanghai Hotel, Shanghai, China
    Contacts: Luke Xia
    Tel: +86 21 6053 8962
     
    Generic Product Development is An Art of Science? Current Philosophy and Understanding in Light of Business Globalization
     
    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.
     
    Topic Highlight
    • 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
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