Dublin, Dec. 10, 2024 (GLOBE NEWSWIRE) -- The "Pharmaceutical Regulatory Affairs in China Training Course" has been added to ResearchAndMarkets.com's offering.
This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan.
The two-day course 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
Benefits of attending:
- Gain an overview of the regulatory procedures in the region
- Understand and assess the impact of recent regulatory reforms
- Discuss clinical product development and Chinese-specific approaches
- Understand requirements for import and local manufacturing registration
- Discuss product registration strategies
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
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 or refresher course.
Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities.
Course Agenda:
General introduction to the PRC and the pharmaceutical market
- Commercial and cultural background
P.R. China - Drug Regulatory Systems
- Regulatory authorities
- Recent regulatory changes
- Regulations and guidelines
- Drug classification systems
- Import and local manufacturing registration
- Data requirements
- Registration requirements
- Labelling requirements
P.R. China - 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
P.R. China - Regulatory Strategies
P.R. China - Health Authority Interactions
P.R. China - Maintenance
Taiwan (Republic of China)
- Cultural background
- Regulatory authorities
- Regulations and guidelines
- Drug classification systems
- Data requirements
- Country-specific matters
P.R China - Recent Developments
For more information about this conference visit https://www.researchandmarkets.com/r/vj7uad
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