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

Level:
Foundation
Area:
Drug Development
Code:
DDF50
Duration:
03:30:00
Workshop profile:
This introductory workshop is designed for participants with little or no experience of the drug development process or the regulatory documents required.
Objective:
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.
Content:
The following documents will be described in the order they are needed in drug development: 1. Clinical Trials • Investigator’s brochure (IB) • Investigational medicinal product dossier (IMPD) • Clinical study protocol (CSP) and synopsis • Patient information and informed consent forms (ICF) • Clinical study report (CSR) • Lay summary of clinical trial results • Drug safety update reports (DSURs) 2. Clinical Development and Regulatory Strategy • Paediatric investigation plan (PIP) • Orphan drug application (ODA) • Risk management plan (RMP) 3. Marketing Authorisation Application • Common technical document (CTD) clinical modules • Summary of product characteristics (SmPC) • Package Leaflet 4. Post Approval documents Periodic Benefit-Risk Evaluation Report (PBRER) For each document, the following will be summarised: • Who will use it and how it will be used • Who is involved in its preparation and what is the role of the medical writer • Where the information in each document comes from • How it fits with the other documents during drug development • What are the applicable regulatory guidelines, template(s) and styles used