ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We'll discuss the expected changes and potential impact on viral safety strategies.
In this webinar, you will learn:
- The Importance of virus testing in biologics products
- Regulatory landscape, expectations for the Q5A revision
- Examples of alternate testing schedules, impact on viral clearance