Event Date/Time: Jul 18, 2005
End Date/Time: Jul 19, 2005
The Institute for International Research is pleased to present our annual Chemistry Manufacturing and Controls conference, where you will learn practical approaches for harmonizing global dossiers. Despite visions of “one dossier, one world”, regulatory agencies and industries remain in the early stages of harmonizing CMC content for Clinical Trial Applications in the EU, and Investigational New Drug Applications in the US. This conference explores successful approaches for building approvable CMC sections for the US, EU and beyond. You will learn how to streamline documents while addressing country-specific requirements.