IQ Webinar: Scientific and Regulatory Considerations for Long-acting Injectable Suspensions
Scientific and Regulatory Considerations for Long-acting Injectable Suspensions
21 July 2023
11:00 AM – 12:00 PM ET
Presented by the Long-Acting Injectables Working Group
Sponsored by the IQ Drug Product Leadership Group
Long-acting injectable (LAI) suspensions has been emerging as a new formulation modality of patient centricity. There has been an increasing number of LAI suspension products approved by the Agency in recent years. However, the research and development of LAI suspensions are facing tremendous challenges due to the lack of understanding of the formulation, in vitro release and in vitro-in vivo correlations or relationship (IVIVC/IVIVR). In addition, there has been no guidance for industry regarding this area.
We are delighted to invite the speaker Dr. Yan Wang from the US FDA to give us a talk, covering topics such as IVIVC and related areas of LAI drug suspensions. Dr. Wang is currently the Acting Team Lead at US FDA CDER, focusing on long-acting injectable products. The webinar will provide scientific and regulatory considerations for long-acting injectable suspension products.
This webinar series is open to the general public, and membership in the IQ Consortium is not required.