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Proactive Strategies in Advanced Therapy Safety Management

The landscape of medical treatment is evolving rapidly, particularly with the emergence of advanced therapies such as cell and gene therapies. The complexities involved in these innovative treatments bring unique safety challenges that professionals in the healthcare industry must address proactively. A free and insightful webinar hosted by Xtalks, titled Advanced Therapy Safety Management: Proactive Strategies for Real-World Risk Detection, aims to shine a light on these critical safety issues.

Understanding Advanced Therapies

Advanced therapies, including CAR-T, T cell engagers, and mRNA products, present immense potential for treating various diseases. However, they are also associated with intricate safety challenges due to their distinct mechanisms of action and manufacturing processes. For example, these therapies often result in immune-mediated side effects, such as cytokine release syndrome (CRS) and neurotoxicity, alongside delayed adverse reactions like secondary malignancies. Therefore, ongoing safety monitoring from the early phases of therapy development through to post-marketing is absolutely essential for ensuring patient safety and navigating regulatory landscapes effectively.

The Need for Proactive Safety Monitoring

In light of regulatory bodies demanding enhanced pharmacovigilance efforts, including long-term patient registries and post-authorization safety studies, the importance of long-term safety monitoring strategies becomes clear. These processes are crucial not only for guaranteeing patient safety but also for expediting the development of these transformative therapies. Small clinical trials often lead to limited safety data, which poses a challenge in real-world applications.

During this webinar, experts will explore how to manage immune-related toxicities, analyze real-world safety signals, and adapt follow-up strategies tailored to diverse patient groups. By utilizing techniques such as PASS (Post-Authorization Safety Studies) and patient registries, participants will receive excellent practical insights into designing comprehensive safety monitoring strategies aligned with regulatory expectations from bodies such as the EMA, FDA, and MHRA.

Webinar Agenda and Speakers

On September 25, 2025, at 11 am EDT (4 pm BST/UK), Xtalks will host an expert panel comprising key figures in pharmacovigilance and medical affairs. Notable speakers include Ian Kovacs, PhD, Global Head of Pharmacovigilance; Desmond Cabrera, Vice President and Global Head of Cell and Gene Therapy; Oksana Fabri, MD, PhD, Senior Medical Director; and Georgia Kolangi, MSc, Associate Director of Pharmacovigilance. Their combined expertise will provide attendees with valuable insights into emerging safety risks and the importance of effective safety communication strategies.

Key Takeaways for Attendees

Participants of this enlightening webinar can expect to learn about:

• - Strategies for the early identification of safety risks using real-world data and clinical insights.
• - The vital role of tailored risk minimization instruments in managing complex safety profiles.
• - Best practices for stakeholder engagement, along with the development of clear educational materials to promote safe usage of advanced therapies.
• - The importance of robust traceability systems in enhancing patient safety over the course of treatment.

By addressing these topics, the webinar will empower healthcare professionals to design more effective pharmacovigilance strategies while ensuring that patients continue to receive safe and effective treatment.

Register Now

This is an unmissable opportunity for all professionals involved in the development and management of advanced therapies. To register for the webinar and to find out more information, please visit Advanced Therapy Safety Management.

Engaging with this content could significantly enhance your understanding of the safety challenges present in advanced therapy administration and help you stay ahead in a field that evolves rapidly.

Xtalks stands as a significant platform for professionals in life sciences, enhancing access to critical educational content and enabling attendees to keep pace with industry developments. Join this impactful session and deepen your knowledge of safety management in advanced therapies.