Navigating Regulatory Pathways for Ophthalmic Gene Therapies
Time: 1:00 pm
day: Pre-Conference Workshop Day Clinical Track PM
Details:
With the evolving landscape of gene therapy and regulatory frameworks, understanding and effectively navigating
regulatory pathways are crucial for the development and approval of ophthalmic gene therapies. This workshop
provides insights into regulatory challenges, collaboration strategies, and innovative approaches to accelerate the
approval process for breakthrough ocular gene therapies.
Key Discussion Points:
- Regulatory Landscape Overview: Understanding diverse regulatory frameworks and challenges across regions. Discussing harmonization efforts and strategies for compliance with regulatory guidelines.
- Addressing Safety and Efficacy Concerns: Highlighting complexities in long-term safety assessment and strategies for risk mitigation. Exploring translational challenges and robust risk-benefit analyses in regulatory decision-making.
- Regulatory Considerations for Emerging Technologies: Examining pathways for novel delivery platforms like suprachoroidal and subretinal systems. Discussing standardization challenges and the role of real-world evidence in supporting submissions.
- Accelerating Regulatory Approval for Breakthrough Therapies: Overview of expedited pathways and emphasizing proactive engagement with regulatory agencies.
By the end of this workshop, participants will gain an understanding of the regulatory landscape and acquire practical strategies to navigate challenges, collaborate effectively with regulatory agencies, and expedite the approval process for breakthrough ocular gene therapies.
Speakers:
