DDA28a The Investigational Medicinal Product Dossier: a critical component of the Clinical Trial Application

Participants of this workshop will get an overview on the individual parts of the IMPD, as well as details of the relevant source documents. In addition, participants will be informed about the medical writer’s role in the preparation of the IMPD.

Participant profile: The Investigational Medicinal Product Dossier (IMPD) is an important component of the clinical trial application (CTA) which is submitted for approval of clinical trials on investigational medicinal products (IMPs) in the EU. Those who stand to benefit from this workshop are regulatory personnel and medical writers in the pharmaceutical industry, CROs, and medical writing agencies who are involved in preparing regulatory documentation.

Participants of this workshop will be expected to have basic knowledge, if not experience, of the drug development and approval process, especially in the US and the EU.