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Press Release

Two Day Pharmaceutical Regulatory Affairs in China Seminar (Basel, Switzerland - November 24th-25th, 2016) - Research and Markets

Research and Markets
Posted on: 07 Oct 16

Research and Markets has announced the addition of the "Pharmaceutical Regulatory Affairs in China" conference to their 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 ll important aspects of gaining and maintaining a successful Marketing Authorisation in the region

- Drug regulatory systems

- An overview of import and local manufacture registration

- Clinical product development including CMC regulatory requirements

- An interpretation of practical aspects

- Recent developments

- The opportunity to exchange experiences with other delegates


Programme Day One

General Introduction to Peoples Republic of China and the Pharmaceutical Market

- Commercial and Cultural Background

Drug Regulatory Systems

- Regulatory Authorities

- 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

- 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

Programme 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

- - Regulatiory procedures

- Documentation expectations

Taiwan (Republic of China)

- Cultural Background

- Regulatory Authorities

- Regulation and Guidelines

- Drug Classifications Systems

- Data Requirements

- Country specific matters

P.R. China

- Health Authorities Interactions

- Recent Regulatory Developments

Final Discussion

Summary and conclusions of the Seminar

For more information about this conference visit

View source version on

Business Wire

Last updated on: 07/10/2016

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