3rd Edition of Cell & Gene Therapy World Conference 2027
Speakers - cgtwc2026
Mana Alshehri
Mana Alshehri
- Designation: Senior Scientific Evaluation Expert at the Saudi Food and Drug Authority
- Country: Saudi Arabia
- Title: Navigating ATMP Regulation in Saudi Arabia From Clinical Trial Authorization to Marketing Approval
Abstract
Advanced therapy medicinal products (ATMPs), including cell and gene therapies, present distinctive regulatory challenges due to their scientific complexity, specialized manufacturing, limited clinical populations, and potential long-term risks. This presentation provides a practical overview of the Saudi regulatory pathway, from product classification and engagement with the Saudi Food and Drug Authority (SFDA) to clinical trial authorization, marketing approval, and post-approval oversight. It will summarize the key expectations for quality, nonclinical and clinical evidence, manufacturing controls, safety monitoring, pharmacovigilance, and long-term follow-up. The presentation will also examine how early regulatory engagement and robust scientific evidence can accelerate development without compromising quality or patient safety. Technology transfer and local manufacturing will also be addressed as Saudi Arabia continues to expand its advanced-therapy ecosystem.
The 3rd Edition of Cell & Gene Therapy World Conference (CGTWC 2027) is one of those leading events that would stand high in biology and medical science. CGTWC 2027 ...
Read More>>
Organizer
