Webinar: Managing safety reporting in the evolving regulatory environment in the Asia Pacific region

Managing safety cases is becoming more complex due to the ever-increasing volume and variety of data.  In the Asia Pacific region specifically, regulatory and legal requirements vary from country to country and this is additionally layered by intricate country language requirements.

Over the last few years, pharmacovigilance requirements have evolved considerably and more changes are on the horizon. 

This webinar will provide an insight into safety regulations in Taiwan, China and Japan, delving deeper into the recent and upcoming safety regulations in Korea, to support understanding and compliance in pharmacovigilance. It will cover the latest regulatory intelligence, medical writing customisations and explore methods to achieve operational efficiency through system optimization.

Learning objectives:

• Regulatory requirements in APAC region relating to:
  • E2B R3 regulatory requirements
  • Periodic reporting
• Implementation approach for evolving requirements
• DSUR/PSUR process and customisation requirements
• Understanding of technology system to achieve safety reporting efficiency

Audience

This program is intended for Vice Presidents, Executives, Directors, Managers, Associates responsible for oversight, Associates involved in:

• Outsourcing
• Procurement
• Quality Assurance
• Project Management
• Pharmacovigilance
• Safety Reporting
• Medical Affairs
• Regulatory Affairs
• Medical Writing
• Clinical Trials
• Post Marketing