Customized PV Safety Software to Meet Chinese Regulatory Requirements

Download Whitepaper

By clicking ‘Submit’ button, you are agreeing to opt-in to communications from ArisGlobal and use of the above information for ArisGlobal products, news & updates.

Note: You can unsubscribe to email communication from ArisGlobal any time.

The Chinese regulatory environment has responded to an increasingly integrated global pharmaceutical economy with the adoption of a comprehensive product life-cycle regulatory system to ensure the safety and effectiveness of medication use.

This white paper looks at efforts by Chinese manufacturers to establish efficient pharmacovigilance oversight by acquiring pharmacovigilance safety databases such as LifeSphere® Safety Multivigilance (formerly known as ARISc) to comply with the regulatory expectations and global safety-related best practices.

Download the paper to learn more about pharmacovigilance in China and the benefits of LifeSphere Safety Multivigilance, including:

  • Flexible and scalable adverse event reporting
  • Single global database for supporting the drug safety requirements of multiple regions
  • Flexible configuration that can mirror practically any business process
  • Integrated ICH E2B submission support
  • Integrated MedDRA browser
  • Advanced query and ad hoc reporting capability
  • Compliance with international regulatory obligations for reporting adverse events
  • Automation of case processing and report distribution with configurable workflows
  • Shortening data entry, medical review and coding processes
  • Customized to the needs of Chinese pharmacovigilance personnel