Program (Subject to Change)

  • CPhI International Agencies Updates and Q&A Session(Regulatory policies)
CPhI International Agencies Updates and Q&A Session(Regulatory policies)


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Date:06月19日 09:00 - 06月19日 17:30

Language: Chinese-English

Location:Hall E2 M19 Meeting Room


Introduction:Experts from the NMPA, FDA, EDQM, WHO, and drug regulators and pharmacopoeia commissions of various countries will be present to share the recent dynamics of drug regulatory policies and regulations and help enterprises improve levels in terms of product registration application and quality system construction. The event will not only serve as a high-end, open, and sharing platform for Chinese and overseas pharmaceutical industries to exchange on drug regulatory laws and regulations, but also an important window for Chinese pharmaceutical industry to be synonymous with international standards.


Contact:Liu Weiqi, 010-58036334,

  • 09:00-09:30 Registration
  • 09:30-09:40 Opening Remarks


  • 09:40-10:10 Updates on Chinese Pharmacopeia 2020 and Interpretations on Volume VI

    Zhang Wei  ChP  Secretary General

  • 10:10-10:40 China’s Engagement in ICH and ICH Guideline Translation in China


  • 10:40-11:10 Key Points of Drug Inspection


  • 11:10-11:40 Evaluation and Implementing Strategies of ICH Q4 and Relevant ChP

    Hong Xiaoxu  ChP  Director

  • 11:40-12:10 Progress of Standards Development of International Pharmacopeia

    Sabine Kopp  Drug QA Unit of WHO  

  • 12:10-12:30 Q&A

    All experts    

  • 12:30-13:30 Lunch Break
  • 13:30-14:00 Trends in FDA Assessment of Drug Applications—Advice to Industry

    Howard R. Sklamberg    Partner,AKIN GUMP

  • 14:00-14:30 Regulation Updates on Drug Assessment and Inspection by FDA

    US FDA    

  • 14:30-15:00 Analysis of Deficiencies in CEP Dossiers and Site Inspection


  • 15:00-15:30 Trends of Drug Regulation in the UK and Standards Revisions of BP

    James Pound  MHRA, BP  

  • 15:30-16:00 Experience Sharing by WuXi Biologics on GMP Certification in the US and EU

    Dr. Chiang Syin  WuXi Biologics  CQO

    Dr. Gang Wang  WuXi Biologics  VP of Biologics Quality

  • 16:00-17:30 Institutional Changes and Policy Updates of WHO PQP

    WHO Prequalification Team    

  • 17:30-17:40 Q&A


  • MHRA一对一咨询(需提前申请并填写报名表) 时间: 2019年6月18日(仅一天) 9:30-16:30 地点:上海浦东嘉里大酒店三楼商务中心3号会议室
  • One-on-One meeting (*Pre-registration form is needed to schedule the meeting) Time: June 18-20,2019 9:30-16:30  Venue: Tower Function Room 3, Kerry Hotel Pudong
  • One-on-One meeting (*Pre-registration form is needed to schedule the meeting) Time: June 18-20, 2019 9:30-16:30 Venue: E1F35, SNIEC