This course delves into the world of additional Risk Minimisation Measures (aRMMs), providing a thorough understanding of their development, implementation and assessment. Participants will explore the regulatory framework surrounding aRMMs, learn how to design effective risk minimisation strategies and evaluate their impact on patient safety and healthcare outcomes. This course combines theoretical knowledge with practical insights, enabling attendees to enhance their skills in managing and monitoring aRMMs in their organisations.
Benefits of attending
- Gain in-depth knowledge of aRMMs, including their purpose, development and regulatory requirements
- Learn how to create and implement effective risk minimisation strategies tailored to specific safety concerns
- Discover methods for assessing the effectiveness of aRMMs and making data-driven improvements
- Stay informed about the latest regulatory guidelines and best practices for aRMMs
- Explore the ethical aspects of implementing aRMMs and ensuring patient safety
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Course Content
Introduction to aRMMs
- Overview of additional Risk Minimisation Measures
- Importance and objectives of aRMMs and their effectiveness evaluation
Understanding global regulatory guidelines for aRMMs
- Key regulatory requirements and compliance
- How new safety data affects decisions and benefit-risk balance
Principles of designing risk minimization strategies
- Designing Effective aRMMs
- Case study on aRMM implementations
Practical approaches to implementing aRMMs
- Implementation Strategies: Engaging stakeholders and ensuring adherence
- Real-world scenarios and problem-solving
Methods for monitoring and assessing the impact of aRMMs
- Data collection, analysis, and reporting
- Ethics in aRMM Implementation
Who Should Attend
- Pharmacovigilance specialists
- Drug Safety Officers
- Regulatory affairs professionals
- Clinical research associates
- Medical affairs personnel
- Risk management professionals
- Healthcare Quality Assurance specialists
