online,

Hollywood,

Florida,

United States,

ZIP: 33021

Phone: 844-267-7299 | 954-947-5671

Overview

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
REMS are not designed to mitigate all the adverse events of a medication, these are communicated to health care providers in the medication’s prescribing information. Rather, REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.

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Course Goal
1. Provide an overview of the REMS program to help applicants prepare for BIMO REMS Inspections
2 . Provide best practices to address inspection findings

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Session Highlights
- Overview of REMS Elements
- Shared Systems REMS
- The REMS Inspection Process
- Best Practices to Address Inspection Findings
- REMS Specific Issues
- Preparing for REMS Inspections
 

Who Will Benefit

This webinar will provide valuable assistance to the following personnel in pharmaceutical manufacturing, drug, biologic and clinical research companies:

• Regulatory Affairs

• Compliance

• Clinical Research Administrators

• Study Sponsors

• Legal

• Senior Management (production, supply chain and operations)

 

Ms. Kelly Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.