Risk Evaluation and Mitigation Strategy (REMS) Inspections
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"
Mitigate all the adverse events of a medication
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.
1. Provide an overview of the REMS program to help applicants prepare for BIMO REMS Inspections
2 . Provide best practices to address inspection findings
• 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
• Clinical Research Administrators
• Study Sponsors
• Senior Management (production, supply chain and operations)
Industries who can attend
This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.