11 December 2018
12:00 – 1:00 pm EST
The Food & Drug Administration Safety and Innovation Act (FDASIA) of 2012 amended the Risk Evaluation and Mitigation Strategies (REMS) modification provisions. FDASIA identified different types of REMS changes and directed FDA to issue guidance. FDA issued the Risk Evaluation and Mitigation Strategies: Modification and Revision - Guidance for Industry in April 2015.
This webcast will provide an overview of the REMS: Modification and Revision Guidance. You will learn about the different types of REMS changes and how to submit the different types of REMS changes to FDA. You will also learn about FDA’s process for reviewing and acting on different types of REMS changes.
Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Learning Objectives
Upon the webcast's conclusion, you will be able to:
- Understand the different categories of REMS changes in the draft guidance
- Understand the application holder submission procedures for the different types of REMS changes
- Understand FDA’s proposed process for reviewing and acting on different types of REMS changes
Who should attend?
Professionals involved in:
- Risk Evaluation and Mitigation Strategies (REMS)
- Regulatory Affairs
- Risk Management
Speaker
Brian Gordon, MA, regulatory health policy analyst, Food and Drug Administration
Brian Gordon is a regulatory health policy analyst in the Division of Risk Management (DRISK) in FDA’s Office of Medication Error Prevention and Risk Management within the Office of Surveillance and Epidemiology (OSE). He has been with the FDA since 2008. He works on developing and implementing policies and processes related to REMS.