There are many reasons why one may need to consider a change in the film coating that is used on a marketed product. For example, the change could be performance driven that results in a qualitative and / or quantitative change in the coating formulation or a desired change in color for marketing purposes, or a change in vendor for cost reasons.
Join us to learn:
- Understanding of the key technical considerations typically needed to support a film-coating change, as well as the various regulations and guidance documents related to post-approval changes.
- Learning the process for making a change to an IR (immediate release) film coating and what is needed in the U.S. and Europe to make the change in terms of technical studies and other information that may be required for FDA/EMA submissions.
- Discovering what can be done to make these types of changes with minimal regulatory impact or approval delays.
- Understanding of the key technical considerations typically needed to support a film-coating change, as well as the various regulations and guidance documents related to post-approval changes.
- Learning the process for making a change to an IR (immediate release) film coating and what is needed in the U.S. and Europe to make the change in terms of technical studies and other information that may be required for FDA/EMA submissions.
- Discovering what can be done to make these types of changes with minimal regulatory impact or approval delays.