LIFE SCIENCE TRAINING MODULE
The Cradle-to-grave Document Life Cycle of Medicinal Drug Products
An end-to-end description of the core regulated documents involved in the development, registration and post-market life of a medicinal drug product. This training is intended for service providers and freelancers who sell services to the pharmaceutical industry, and who wish to understand controlled documentation and compliance standards. This module offers three separate sessions that can be taken alone or in combination depending on your needs. If you create, process, review or translate regulated content and documentation for medicinal drug products, including clinical studies, these sessions may be especially useful. They may help you serve your clients' needs and understand their document compliance obligations as well as their service demands.
SESSION 1
Introduction to the Regulated Document Life Cycle for Medicinal Drug Products
An introduction to the regulated document life cycle of medicinal drug products and the core scientific data and documents involved in the critical path of a drug’s life. This session takes a high level view of the drug’s life cycle and it’s key regulated documents as defined in the context of harmonised ICH standards (GxPs). For detailed insights into the document content, purposes and intended audiences, refer to sessions 2 and 3 in this module.
SESSION 2
Core Regulated Documents
for Medicinal
Drug Products
A step-by-step walk through the core regulated documents required for the development, regulatory registration, and post-market life of medicinal drug products. The session will provide a detailed understanding of the documents, their purposes, content and intended audiences, and the session is based on internationally harmonised ICH (GxP) document standards.
The session can be taken as a follow-on to session 1 or alone if you already have a basic familiarity with medicinal drug products and their regulated documentation.
SESSION 3
Essential Clinical Documents
for Multinational Clinical
Studies
A deep dive into the essential regulated documents involved in clinical studies for medicinal investigational drugs, as defined under the ICH standard for Good Clinical Practice (GCP). If you work as a service provider, consultant or freelancer for clinical study sponsors or Contract Research Organisations (CROs) and need a comprehensive understanding of clinical documentation, this training will be useful. It includes the full clinical study content life cycle, from documents required for clinical study submissions, to clinical study conduct and clinical study reporting. It also offers a brief introduction to the steps involved in a controlled clinical study. The focus will be on multinational interventional clinical studies.