Medical Writing in Clinical Development

Medical writing plays an increasingly important role in clinical R&D and submission procedures. With the implementation of ICH guidelines, it goes without saying that creating high-quality clinical documents is important for successful applications. Preparing a large number of clinical documents that meet regulatory requirements under extreme time constraints can create a challenge for even the most capable medical writing teams.

This module will take a look at the important role that medical writing plays throughout clinical research and development and how it intersects with other departments. The workshop will explain the strategy of document authoring, including basic contents and processes, and dive into how to author various key clinical documents efficiently.

Workshop Objective

• Acquire an overview of medical writing from both global and China perspectives
• Understand key contributions from Medical Writing in the whole life cycle of drug development
• Acquire key considerations in document authoring by development phase​ and document type

Workshop Outline

• An overview of medical writing: understanding the evolving role of Medical Writing in drug development​

• Key contributions from medical writing
  • Review the work scope of medical writing across the whole life cycle of drug development​
  • Understand key principles in medical writing, such as:
    • Document messaging
    • Document quality management
    • Document development process management

• Discuss the key content requirements and authoring process considerations for various types of documents:
  • Key clinical documents in IND stage: Clinical Study Protocol, Informed Consent, IB
  • Key clinical documents in NDA stage: Clinical Study Reports, Clinical summaries, Clinical Overview​