GMO Application Insights for Clinical Trials 🚀

🔬 Webinar: GMO Regulatory Challenges in Clinical Trials | May 2025

The use of Genetically Modified Organisms (GMOs) in clinical trials requires navigating a complex web of regulatory requirements that vary from country to country. In this exclusive Ask the Experts session, our regulatory leaders at VCLS break down the global framework for GMO submissions, from the EU to the US, UK, Switzerland, Japan, and beyond.

📌 In this session, we’ll cover:
✅ What qualifies as a GMO-IMP and which products are excluded
✅ Differences between contained use and deliberate release in EU regulations
✅ Best practices for preparing a harmonized GMO dossier
✅ Global submission timelines, risk assessments, and local authority interactions
✅ How to prevent regulatory delays and optimize your trial readiness

💡 Whether you’re preparing a clinical trial with a viral vector, CAR-T cells, or live biotherapeutic product, this webinar will help you strategically plan your GMO submissions and mitigate risk across global sites.

📅 Don’t miss this in-depth regulatory session designed for clinical, CMC, and regulatory teams involved in advanced therapies.

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