US FDA - Understanding Key Factors When Working with the FDA
This course has been designed to provide an essential overview of the key factors when working with the FDA. It will equip senior managers and project managers with pivotal information to enable them to interact with their teams and ask critical questions to ensure the best outcomes when making applications to the FDA.
The programme will provide an overview of the US FDA’s organisational divisions and examine the drug development regulations. It will provide a valuable guide through the review options and discuss the New Drug Application (NDA) process and how the FDA deals with Generics and Biosimilars.
For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
Upcoming start dates
Suitability - Who should attend?
Benefits of Attending
- Learn the critical factors involved when embarking on product development for the US market
- Understand how to communicate effectively about US activities throughout the organisation
- Know the structure of the FDA and how it works
- Understand how to comply with the regulations and requirements
- Discover the best review process for your application
- Learn the requirements and processes for biologics and advanced therapies
- Review the key differences between the EU and FDA applications for Generics (ANDA) and Biosimilars (315k)
- Get the opportunity to understand the complexities and discuss best approaches with an expert in this area
Request information - obligation free
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