Regulatory Documentation: An Introduction
Regulatory documentation is broadly defined as the documents submitted to health authorities in order to support research, development, marketing applications and post-marketing activities. These documents are considered regulatory because they are intended to meet the requirements under the laws and regulations that pertain to medicinal products. This understanding may or may not be shared with all members of a project team or program team. Therefore, it is critical to define terms and build a basic shared vocabulary at the beginning of any project.
This course will help enable you to make your existing knowledge more accessible to colleagues working in different job functions. In other words, this course is designed to help foster your leadership in the field of regulatory documentation.
At a Glance
- Target Audience: This course is designed to give an overview of some basic principles of regulatory documentation from the perspective of regulatory affairs professionals who must lead teams.
- Total Length of Course: 2 Hours
- RAC Credits: 2
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:
- Understand the concept of regulatory documentation across diverse disciplines, as defined by both domestic and international health authorities.
- Explore the roles and methodologies associated with regulatory documentation in a professional context.
- Evaluate different models and strategies for fostering collaboration within the regulatory affairs field.
- Discover resources and references for obtaining additional information and insights in the realm of regulatory documentation.
Module Titles
- Module 1: Introduction
- Module 2: Principles of Regulatory Documentation
- Module 3: Regulatory Affairs Professionals as Leaders
- Part 1: What Kind of Leadership Can Regulatory Affairs Professionals Provide to Teams
- Part 2: Interpreting Regulatory Guidelines—The Role of Policies and Procedures
- Part 3: Developing Strategies for Regulatory Documentation
- Part 4: Encouraging Critical Thinking—Team Advising and Education
This course is also included in:
