The pharmaceutical industry has experienced a trend in the number of accelerated approval designations for drugs (e.g. orphan drugs, breakthrough therapies, accelerated approvals, and FDA priority reviews) being developed. These designations are given shortened timelines for product development, product assessment and commercial scale-up (typically between 3-5 years) and come with several development and manufacturing challenges.
In this webinar you will hear from industry experts on:
- How to manage stability challenges for accelerated approval programs
- Fit-for-purpose manufacturing strategies
- Overcoming scale-up challenges
- Developing a comprehensive solution for unexpected challenges
- Avoiding typical pitfalls in accelerated programs