This is a new era for many companies as the number of regulatory submissions to China are increasing. There are many questions on the similarities and differences of these compared to other regions. This webinar provides an overview of the China regulations with a specific focus on data and regional requirements for Biologics China clinical trial applications. We share our experience on submissions and approvals of clinical trial applications from our new Guangzhou facility including gap assessments and support of pre-IND meeting with regulators.
Watch this on-demand webinar to learn more about how Lonza can assist with your China clinical trial applications.
Key Learning Objectives:
- Learn about the special challenges and considerations when submitting a clinical trial application in China compared to other territories
- Gain an insight into our gap assessments and pre-IND regulatory support at our new Guangzhou facility
- Find out how Lonza can assist you with clinical trial applications and approvals in China
Who Should View This Webinar:
- Pharmaceutical scientists and engineers involved in clinical trial applications
- Scientists interested in the data requirements for Biologics China clinical trial applications
- Regulatory experts looking to improve their knowledge on the China regulatory landscape
- Decision makers looking to submit a clinical trial application in China