🧾 Course Title:

Mastering PSUR Drafting: A Practical Session for Regulatory Professionals

📘 Course Description:

This intensive master session is designed to equip professionals with the practical knowledge and hands-on skills required to draft high-quality Periodic Safety Update Reports (PSURs) in compliance with global regulatory standards.

Whether you're new to PSUR writing or looking to enhance your expertise, this session covers the end-to-end drafting process, including data collection, risk-benefit evaluation, regulatory expectations (EMA/FDA), and submission best practices.

Led by experienced regulatory experts, the session combines real-world case studies, template walkthroughs, and mock drafting exercises to ensure you're industry-ready.

🎯 What You Will Learn:

• PSUR purpose, scope, and regulatory requirements (ICH E2C(R2), EU Module VII)

• Structuring and formatting PSURs for global markets

• Data sources: Safety database, literature, clinical data

• Writing safety narrative summaries and evaluating benefit-risk profiles

• Practical tips for timelines, version control, and submission readiness

• Common audit findings and how to avoid drafting pitfalls