Pharmacovigilance in China – Current Updates, Challenges and Solutions for the Industry

Jun 7, 2018

The Chinese Federal Drug Authority (CFDA) regulations are changing and that brings both challenges and opportunities. The introduction of the E2B(R3) mandate pushed the local Chinese pharmaceutical market to scramble.  There might be breathing room now with the update to accept E2B(R2) submissions for another year, but the clock is ticking.

Innovative solutions for the pharmaceutical industry are necessary to meet the CFDA regulation for pharmacovigilance and clinical safety, along with full compliance with E2B(R3) guidelines with complete localization.  Forward thinking Chinese organizations are looking to future proof their PV solutions, while maintaining continuous compliance.

By adopting newer technologies that incorporate machine learning and artificial intelligence, systems can be future-proofed and meet the challenges head-on. This webinar will look at the impact of the latest CFDA announcement on ICSR reporting as well as existing and expected submissions.

This webinar:

  • Addresses the latest CFDA regulations announcement and the impact on domestic and global companies
  • Explores What is required to be compliant with the latest regulations
  • Provide a ‘first hand’ view into what a compliant, AI driven product can do – in localized language.
  • Discuss cognitive computing technologies available

The Chinese Federal Drug Authority (CFDA) regulations are changing and that brings both challenges and opportunities. The introduction of the E2B(R3) mandate pushed the local Chinese pharmaceutical market to scramble.  There might be breathing room now with the update to accept E2B(R2) submissions for another year, but the clock is ticking.

Innovative solutions for the pharmaceutical industry are necessary to meet the CFDA regulation for pharmacovigilance and clinical safety, along with full compliance with E2B(R3) guidelines with complete localization.  Forward thinking Chinese organizations are looking to future proof their PV solutions, while maintaining continuous compliance.

By adopting newer technologies that incorporate machine learning and artificial intelligence, systems can be future-proofed and meet the challenges head-on. This webinar will look at the impact of the latest CFDA announcement on ICSR reporting as well as existing and expected submissions.

This webinar:

  • Addresses the latest CFDA regulations announcement and the impact on domestic and global companies
  • Explores What is required to be compliant with the latest regulations
  • Provide a ‘first hand’ view into what a compliant, AI driven product can do – in localized language.
  • Discuss cognitive computing technologies available
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About ArisGlobal

ArisGlobal is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary Nava® cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

Additional Information

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Contact

Alberto Cantor
ArisGlobal
+1 609-360-4042 | acantor@arisglobal.com