Benefit-Risk Management.
The strategic creation of RMPs & REMS to support your products.

What is Benefit-Risk management?

Benefit-Risk management is the process of evaluating if the benefits for patients or animals from the use of a medicinal or veterinary medicinal product outweigh the associated risks from its use for a particular indication. This assessment results in the creation of a product’s ‘Benefit-Risk profile.’

Evaluation is a continuous process that occurs throughout all stages of a product’s life cycle, from pre-marketing to post-marketing, and it adapts as new information becomes available.

Information could be sourced from Adverse Event Reports (AERs), Individual Case Safety Reports (ICSRs), Signal Management, Literature Monitoring, and other channels, including periodic assessments using Periodic Safety Update Reports (PSURs).

The cumulative data from these various sources can either positively or negatively affect the balance of the Benefit-Risk profile of the product.

Click here for more information from the EMA on Benefit-Risk Management.

What is a Risk Management Plan (RMP)?

When is an RMP required?

A Risk Management Plan (RMP) should be included during the application for marketing authorization, or it may be demanded by the European Medicines Agency (EMA) or National Competent Authorities if authorization was granted without one in the past.

RMPs must undergo revisions whenever there are alterations to the risk management system, particularly in cases of adjustments to the Benefit-Risk profile or the attainment of significant pharmacovigilance or risk-minimization objectives.

This updating is necessary to align the RMP with the most recent information available.

Click for more information from the EMA on RMPs.

What must be included in an RMP?

  • A public-friendly summary format which the EMA publishes.
  • The identification and characterization of the medicinal product’s safety profile.
  • The pharmacovigilance activities planned to characterize existing risks and identify any new risks.
  • A Risk Evaluation and Mitigation Strategy (REMS) to implement and assess the effectiveness of these activities.
  • Any post-marketing approval requirements for marketing authorisation.

 

Click for more information from the EMA on RMPs for authorized products.

How Aegisana’s Benefit-Risk services can support you?

Minimising risk, maximising safety.

The Aegisana Pharmacovigilance team is well-equipped to oversee your entire Benefit-Risk strategy, with extensive expertise in streamlined risk management techniques and semi-quantitative methodologies crucial for effective Benefit-Risk assessment.

This extends to creating comprehensive Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) that align with all the requirements of the European Medicines Agency (EMA).

We also know how to apply this knowledge strategically to minimise evaluation feedback and mitigate the potential costs associated with mandated studies or additional Risk Minimization Measures (aRMM).

Flexibility with focus.

Additionally, we can customize RMPs and REMS to fit the specific needs of local authorities and situations. For example, this may involve addressing safety concerns for a prominent population or adapting RMPs to local languages or formats.

Our principal objective, as always, is to foster trust and confidence in our services. Managing Benefit-Risk and creating compliant and authoritative RMPs and REMS is one more way through which we aim to achieve this.

Our focus remains on safeguarding the well-being of your patients, ensuring the safety of your products, and confirming that you’ve made the right choice in partnering with us for pharmacovigilance services.