Presented by
Management Forum
Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP) In-house Training
A comprehensive comparison between the importance Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) in drug safety.
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
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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.
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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
Graeme Ladds
PharSafer Associates Ltd
Graeme Ladds, Director of PharSafer, has over 30 years’ experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.
Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug–device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.
Germany
- BioNTech SE
- CHEPLAPHARM Arzneimittel GmbH
Run Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP) Live online for your team
Half-day
Typical duration
Pricing from:
- GBP 350
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
