-- From Idea to Practice, Gearing up for Pharma QbD through Practical Examples
SHANGHAI, Feb. 5, 2013 /CNW/ - Quality by Design China 2013, organized by CPhI Conferences, will be held on 17th - 18th April in Shanghai, China.
Due to the proposing of the drug quality documents from FDA and ICH, Quality by Design has been the consensus of the pharmaceutical industry. With the rapid development of export to the US and EU, each company has the strong demand to deeply understand the QbD regulation in FDA and EMA and it is necessary for them to master the methodology of QbD application to bring QbD from idea to practice. At the same time, the requirement of QbD application has been added into the generics registration documents in FDA from January 2013. The FDA will no longer accept application documents without QbD content, and this is a challenge for Chinese companies.
Above that background, Quality by Design China 2013 emerges as the times require. It will gather 100+ decision makers from both government institutions and pharmaceutical companies to discuss hot topics including QbD Principles, QbD Implementation Standard, QbD Applications & case study and QbD Regulations. It will also provide an interactive communication platform for professionals in the pharmaceutical industry to benchmark your business and technology against 'best in class' and ensure that you have the tools you need to form a coherent and logical strategy.
Key Speakers include:
- Gu Ziqiang, Pharmaceutical Consultant in CMC and GMP, Former US FDA CMC reviewer and GMP Compliance, FDA
- Pedro Hernandez, Senior Director Quality Assurance, Frontage Laboratories Inc.
- Chen Binhua, General Manager, Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd
- Chen Yisheng, Vice President, Novast Laboratories (China) LTD
- Mei Xuefeng, Director, Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Ms. Tracy Cui
Tel: +86-21-6157 3919
Email: [email protected]
SOURCE: CPhI Conferences
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