DDF55 – Converting an Investigational New Drug (IND) application into an Investigational Medicinal Product Dossier (IMPD): process, regulatory requirements and potential pitfalls

Description

Participants of this workshop will get familiar with the differences and similarities between the IND and IMPD and will be equipped for preparing a full IMPD document using IND as a source and starting point.

Participant profile: This course is intended for medical writers with some experience in regulatory writing and already familiar with the drug development process.