World Drug Safety Congress Europe, 2025
Advanced therapies are transforming the treatment landscape, yet their development and use present unique challenges in clinical safety and pharmacovigilance. This session will highlight key safety concerns and emerging/unknown risks, emerging frameworks with surveillance, and real-world evidence to strengthen risk management. By navigating with proactive safety strategies, stakeholders can enable innovation while ensuring patient safety and maintaining public trust in advanced therapies.
Key Takeaways:
- Key safety concerns with cellular and gene therapies: Explore known and unknown risks raising concerns about the safety of these therapies
- Evolving regulatory landscape: Understand how regulatory requirements are adapting to emerging risks while balancing faster access to therapies
- Best Practices in safety data management and robust risk mitigation strategies: Importance of real-time regulatory intelligence and patient-centred approaches
Why Partner with APCER?
Meet Our Team
Dr. Vineet Kacker
Managing Director & Global Technical Head
Dr Frank Laschewski
QPPV
Dr Kanwalpreet Kaur
QPPV & Head of Strategic Development Group
Indrani Pathak
General Manager -Inside Sales