World Orphan Drug Congress USA 2025

Date: April 22nd–24th, 2025

Location: Boston, USA

PharSafer® is delighted to confirm our participation in the World Orphan Drug Congress USA 2025, one of the foremost global events dedicated to orphan drug development, rare disease research, and regulatory innovation.​

Exclusive Speaker Session

Join Dr. Graeme Ladds, CEO of PharSafer®, for his keynote presentation:

“Safety & Compliance Without Borders: The Orphan Drug Safety Regulatory Checklist”

In this must-attend session, Dr. Ladds will share expert guidance on building a compliant global safety strategy for orphan and ultra-orphan drug development — from early clinical trials to long-term post-marketing surveillance. Drawing from decades of regulatory experience, this talk explores:

• Navigating regulatory divergences across the FDA, EMA, MHRA, Health Canada, and more
• Real-world case studies and practical tools to transform global compliance into a competitive advantage
• Strategies to manage compassionate use, rare patient populations, and long-term safety
• How to leverage automation to ensure efficiency and data integrity

Ideal for: Regulatory affairs professionals, rare disease developers, PV leaders, clinical operations teams, and biotech innovators looking to expand globally while remaining compliant.

Attendees will leave with a deeper understanding of global safety challenges — and a clear checklist to enhance compliance readiness across international markets.

​Connect with PharSafer® in Boston

Our senior team will be available throughout the event and would welcome the opportunity to discuss your organisation’s challenges and explore tailored solutions across:

• Clinical & Post-Marketing Pharmacovigilance
• Global Regulatory Strategy & Risk Management Planning
• Auditing, Training & Inspection Readiness
• Medical Affairs & Safety Communication
• Safety Automation with RAPTAR®​

Schedule a Meeting

To ensure a dedicated time with our experts, we encourage you to schedule your meeting with us in advance.

We look forward to connecting with you in Boston for an inspiring and impactful event.

Note: For more information about the event, please visit: World Orphan Drug Congress 2025.