Additional Risk Minimization Measures (aRMMs) and Their Effectiveness In-house Training

Delve into the world of additional Risk Minimization Measures (aRMMs) and explore everything from the regulatory framework surrounding aRMMs to their impact on patient safety and healthcare outcomes.

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Format: Live online
CPD: 3 hours for your records
Certificate of completion

Course overview

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.

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 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

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 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 affect 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

Graeme Ladds
PharSafer Associates Ltd

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

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