Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP) In-house Training

Course overview

On this course, participants will gain an in-depth understanding of the purposes, regulatory requirements, and practical implementations of both Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) and their importance on drug safety. The course will highlight key differences and similarities and provide real-world examples to illustrate how each document is applied to the same product.

 

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Benefits of attending

• Gain a thorough understanding of REMS and RMP, including their purposes and regulatory contexts
• Learn to differentiate between REMS and RMP, focusing on their unique and overlapping aspects
• Discover best practices for developing and implementing REMS and RMP
• Enhance your skills in regulatory compliance and risk management within the pharmaceutical industry
• Analyse real-world example to understand practical applications and challenges

Who should attend?

• Pharmacovigilance specialists
• Drug safety officers
• Regulatory affairs professionals
• Clinical research associates
• Medical affairs personnel
• Risk management professionals
• Healthcare quality assurance specialists