# Risk Management Overview

Learn how SafetyDocs supports risk management.

## About Risk Management
Risk management is a key component of the pharmacovigilance process, focused on preventing or mitigating the risks a product might pose to patients. In the context of SafetyDocs, risk management is handled using:
- _Risk Management Plans_
- _Risk Measures_
- _Implementation Strategies_

## Risk Management Plans
A risk management plan (RMP) is a document that defines a marketed product's safety profile, including its epidemiology, pharmacovigilance plan, post-authorization studies, and risk minimization activities. SafetyDocs supports the creation of RMPs using the following objects:
- A _Core Risk Management Plan_, which represents a product's global, or company-wide, RMP
- A _Local Risk Management Plan_, which tailors a _Core Risk Management Plan_ for submission to a specific local agency, such as the FDA or EMA

To learn more about managing RMPs in SafetyDocs, see <a href="/en/lr/835593/">Manage Risk Management Plans</a>.

## Risk Measures
A risk measure, also known as a risk minimization measure (RMM), is an element of a product's RMP that identifies a specific risk to be tracked, managed, and measured. Based on its focus, an RMM is categorized as either routine or additional. Some examples of routine RMMs include labeling, product legal status (for example, prescription or hospital-only), and pack size. Some examples of additional RMMs (aRMMs) include demonstration kits, dispensing forms, and direct healthcare professional communications.

In the context of SafetyDocs, risk measures are created from within an existing _Risk Management Plan_ and are defined as either _Core Risk Measures_ or _Local Risk Measures_.

To learn more about managing risk measures in SafetyDocs, see <a href="/en/lr/835605/">Manage Risk Measures</a>.

## Implementation Strategies
An implementation strategy is an element of an RMP focused on how to implement a given risk measure. In the context of SafetyDocs, implementation strategies exist in relation to a given RMP and often include documents describing the implementation plan for a given risk measure. 

As such, SafetyDocs defines implementation strategies as either _Core Implementation Strategies_ or _Local Implementation Strategies_, based on their related _Risk Management Plan_.

To learn more about managing implementation strategies in SafetyDocs, see <a href="/en/lr/835606/">Manage Implementation Strategies</a>.