Overview:

This expert-level course focuses on the critical aspects of regulatory reporting in Pharmacovigilance, highlighting the importance of accurate and timely reporting of adverse events to regulatory authorities. The course covers expedited reporting, aggregate reports, country-specific regulatory requirements, and compliance tracking. Through hands-on exercises and real-world scenarios, learners will gain the skills to ensure adherence to global regulatory standards and avoid compliance risks.

Objectives:

1. To provide a comprehensive understanding of regulatory reporting requirements in Pharmacovigilance.
2. To develop skills in preparing and submitting expedited and aggregate safety reports.
3. To understand and apply country-specific regulatory guidelines for reporting.
4. To ensure compliance with timelines, standards, and quality in regulatory submissions.

Outcomes:

By the end of this course, learners will:

• Demonstrate proficiency in preparing and managing regulatory reports, including expedited and aggregate reports.
• Understand and apply country-specific regulations to ensure compliance.
• Manage and track reporting timelines and ensure adherence to regulatory requirements.
• Build confidence in preparing audit-ready reports and handling regulatory submissions effectively.