What you will learn
- To understand the drug development process in the USA
- Detailed knowledge of US-specific documentation requirements and the procedures and practices of the FDA
- How to reach agreement with the FDA so that development plans provide acceptable study results
- How to analyze and evaluate development plans in terms of the use of best practices required by the FDA
- How to play an important role in any project team working on drug development in the USA
What your company will get
- A regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
- A regulatory professional who is able to provide valuable input to all other team members working with drug development plans in the USA.
- An employee who can play an important strategic role in project teams working on obtaining a marketing authorization in the USA