DDF50 – A Beginner’s Guide to Key Clinical Documents in the EU Drug Development Process

Description

The objective of this workshop is to give new medical writers an overview of the drug development process and the key clinical and regulatory documents commonly required in the EU. The workshop will provide a high level guide to these documents, including their purpose, target audience, the applicable regulatory guidelines, and additional resources (templates, style guides, etc.) that can help new writers prepare these documents.
At the end of this workshop participants will be able to better appreciate the range of regulatory documents and understand how they fit into the different phases of drug development.

Participant profile:This introductory workshop is designed for participants with little or no experience of the drug development process or the regulatory documents required.