Presented by
Management Forum
Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP) In-house Training
A comprehensive comparison between Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP).
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
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). 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
This course will cover:
Introduction to REMS and RMP
- Overview of REMS
- Overview of RMP
- Importance and objectives of REMS and RMP in drug safety
Regulatory framework
- Key regulatory requirements for REMS (FDA perspective)
- Key regulatory requirements for RMP (EMA perspective)
- Global regulatory comparisons and harmonisation efforts
Components of REMS and RMP
- Detailed breakdown of REMS components
- Detailed breakdown of RMP components
- Similarities and differences in structure and content
Developing REMS and RMP
- Processes and best practices for developing effective REMS
- Processes and best practices for developing effective RMP
- Role of stakeholders in the development process
Implementation and management
- Monitoring and managing the effectiveness of REMS and RMP
- Common challenges in developing and implementing REMS and RMP
Case study: comparative analysis
- Presentation of a product with both REMS and RMP
- Detailed comparison of how REMS and RMP address specific risks for the same product
- Lessons learned and best practices
Alina Panourgia
Composite Pharma
Alina Panourgia is an experienced QA/PV Auditor and Regulatory Affairs professional, with a career spanning various regions.
Alina started her career in SEA working at the manufacturing site leading Quality Control/Regulatory Affairs department. She still prepares companies for inspections and provides trainings.
Since relocating to the Middle East in 2015, Alina has worked as a freelancer, collaborating with UK, US and EU companies on PV projects. Additionally, Alina has overseen regulatory submissions and pharmacovigilance activities in the MENA, LATAM and CIS regions.
Alina is a frequent speaker at international forums, conferences and training programs, sharing her expertise on various topics in pharmacovigilance, regulatory affairs and quality improvements.
She has presented at GCC Regulatory Affairs/PV Summits, Drug Safety Symposiums and other significant industry events within MENA region.
