The Us Pharmaceutical Dossier

This seminar will provide an intermediate level introduction into the US CMC Dossier for both an NDA and BLA.

The seminar will focus on the key areas of difference and considerations that differ from the EU in filing a US application.

The procedure, guidelines and structure of the FDA CDER (Centre for Drug Evaluation and Research) and CBER (Centre for Biologic Evaluation and Research) will be discussed and the implications on the CMC Dossier filed will be assessed.

Management of routine interactions with the US FDA will also be covered.

This seminar will provide an insight into all types of CMC submissions including NDAs (505(b)(1) and 505(b)(2)), BLAs, INDs, ANDAs and supplemental applications.