[September 18, 2018]

Pharmaceutical Regulatory Affairs in China Seminar (Basel, Switzerland - November 27-28, 2018) - ResearchAndMarkets.com

The "Pharmaceutical Regulatory Affairs in China" conference has been added to ResearchAndMarkets.com's offering.

This seminar will provide a detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan and will cover all important aspects of gaining and maintaining a successful Marketing Authorisation in the region, CMC regulatory requirements, interpretation of practical aspects and an overview of the requirements for local manufacturing.

This seminar will provide a detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan and will cover:

• All important aspects of gaining and maintaining a successful Marketing Authorisation in the region
• Recent regulatory reforms
• Drug regulatory systems
• An overview of import and local manufacture registration
• Clinical product development including CMC regulatory requirements
• An interpretation of practical aspects
• The opportunity to exchange experiences with other delegates

Who Should Attend:

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance in this region. You will find this seminar useful both as an introductory and or a refresher course.

Previous delegates have included:

Scientists and Technical staff in:

• Regulatory Affairs
• Registration Departments
• Medical Directors

• Analytical Research and Development
• Clinical Development
• Quality Assurance
• New Business Development
• Regulatory Authorities

Agenda:

Day One

General introduction to the People's Republic of China and the pharmaceutical market

• Commercial and cultural background

Drug regulatory systems

• Regulatory authorities
• Recent regulatory changes
• Regulations and guidelines
• Drug classification systems
• Import and local manufacture registration
• Data requirements
• Registration requirements
• Labelling requirements

Clinical product development

• Regulatory aspects of clinical development
• Recent regulatory changes
• Documentation needs including CMC
• Regulatory requirements including GCP aspects
• Chinese specific approaches
• Multinational clinical trials

Hong Kong SAR

• Background overview
• Regulatory authorities
• Regulatory requirements and procedures
• Specific market aspects

Macau SAR

• Brief overview of regulatory aspects

Discussion session

Day two

P.R. China

• Product registration strategies
  • Summary information contrasting import and local manufacture registrations
  • Planning to meet documentation requirements
  • Expediting regulatory approvals
• CMC specific matters
  • CMC regulatory requirements
  • Current standards and future trends
• Variations and renewals
  • Regulatory procedures
• Documentation expectations

Taiwan (Republic of China)

• Cultural background
• Regulatory authorities
• Regulations and guidelines
• Drug classification systems
• Data requirements
• Country specific matters

P.R. China

• Health authority interactions
• Impact of recent regulatory developments

Final discussion

• Summary and conclusions of the seminar

View source version on businesswire.com: https://www.businesswire.com/news/home/20180918005702/en/

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