What you will learn
- The background for generic products
- The possibilities in the legislation for obtaining marketing authorizations with abridged documentation
- How to advise and decide in bioequivalence studies
- How to analyze and evaluate on strategy and choice of regulatory procedure and reference product
What your company will get
- A regulatory professional who understands the characteristics of generic products
- A regulatory professional who can navigate within the regulatory affairs environment for generic products
- A regulatory professional who can advise and decide in bioequivalence studies
- An employee who can play an important strategic role in the analysis, evaluation and decision on regulatory procedure and reference product