The Rising Burden of Pharmacovigilance (PV) Requirements in Early Drug Development

As clinical trials become more complex and sites are spread further across multiple countries and regions, the pharmacovigilance regulatory compliance burden has significantly increased for Sponsors. Specifically designed for early-stage drug development Sponsors, MMS experts explore and share what constitutes a compliant pharmacovigilance program and discuss considerations as the new therapy progresses through key milestones. Understanding of these requirements will help Sponsors properly plan and make informed decisions.

This MMS Experts Insights Webinar is a must-attend event for those involved in the early stages of drug development and will outline how to successfully prepare, implement, and manage your pharmacovigilance strategy to ensure regulatory compliance.

Watch This Webinar To:

• Answer your questions on how pharmacovigilance regulations may affect an early-stage drug development program
• Understand the basics and differences in regulatory reporting requirements among major global health authorities, from individual case safety reports (ICSRs) to aggregate reports
• Learn how to establish processes for signal detection and management in clinical trials

What You Will Learn:

• Detailed background on pharmacovigilance regulations
• What constitutes a compliant pharmacovigilance program
• Pharmacovigilance considerations through key milestones
• How to successfully prepare, implement, and manage your pharmacovigilance strategy

Who Will Benefit From Attending?

• Pharmacovigilance and Drug Safety Professionals from hospitals, pharmaceutical companies, and educational institutions
• Regulatory Affairs and Submissions Professionals
• Periodic Aggregate Safety Report Professionals
• Medical Writing Professionals

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