Description
OVERVIEW
The Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected, and the formulation proposed are suitable for the intended use.
This module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product.
As drug development of the dosage form moves from concept to commercialization, the breadth and depth of CMC documentation required in submissions increases in parallel.
LEARNING OBJECTIVES
• Define the different types of data requirements for type of product
• Describe the general CMC requirements for New Drug Application
• Distinguish CMC information required for special categories
• Understand the Substance part of the Module
• Identify the required information for product part of the module
• Understand how to respond to regulatory authority questions.
KEY TOPICS
- The CMC aspects of the regulatory submission will cover
- Characterization of the active substance
- Raw materials used to manufacture the active substance and finished dosage form
- Description of the product and process development
- Description of the manufacturing processes
- Release and stability testing data for both the active substance and the dosage form
- Analytical methods and specifications used for testing and release of raw materials
- Container and closure systems
WHO WILL ATTEND
Professionals working in:
- Regulatory Affairs staff
- Scientific office staff
- Production manager
- QA Manger
- QC Manager.
