Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.
In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.
Areas Covered:
Contents of IND and IDE
Regulatory requirements for IND and IDE application process
Submissions to IND or IDE to the FDA
Establishing communications with FDA
Type of FDA meetings
Amendments to IND and IDE applications
Progress reports for IND and IDE
Learning Objectives:
Identify the required regulations and guidance documents for drug and device submissions
Use regulations and guidance documents to outline and construct drug and device submissions
Formulate a working knowledge of regulatory submissions, publishing, and style guides
Create checklists that encompass timelines and sections needed from contributors
Who Should Attend:
Regulatory Affairs Management and Staff
Quality Assurance Management and Staff
Manufacturing Management and Staff
Project Managers
Clinical Research Associates
Data Managers
Project Team Leaders
Grant Administrators
Clinical and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process