
Starting 5 - 6 April 2022
Live Online Training Course | 9am - 5pm CEST
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Day One
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Day One
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Reviewing the organisation of the US Food and Drug Administration (FDA) and how this may impact future regulation
- Figen KABADAS OGE, Msc & MBA - Head of Regulatory Affairs, Delpharm
Examining drug development regulations in the US and implications for the industry
Evaluation of review options and obtaining information from the FDA
Analysing the Investigational New Drug Application (IND) and defining the regulatory requirements
Maintaining active INDs successfully
Identifying recent changes and other IND/NDA topics