Benefit-Risk Management

Every product’s benefit-risk balance is under continuous review. Regulators expect you to show that you understand it, manage it and act on new evidence quickly.

Our pharmacovigilance team works as an extension of yours, using structured assessment methods, including semi-quantitative approaches, to deliver clear, well-evidenced benefit-risk assessments. Applied early, that expertise helps avoid delays during evaluation and keeps mandated studies and additional risk minimisation measures (aRMMs) proportionate to the actual risk.

We develop and maintain Risk Management Plans (RMPs) to European Medicines Agency (EMA) requirements, and Risk Evaluation and Mitigation Strategies (REMS) for the US market. Through our network of native-speaking local professionals, we also adapt RMPs to national requirements, including country-specific safety concerns and local languages and formats.

An ongoing assessment

Do the benefits of a product, for a specific indication, outweigh its risks? The answer forms its benefit-risk profile, and it doesn’t stop at approval.

The profile evolves as new evidence arrives, from case reports, signal management, literature monitoring and aggregate reports. Each new piece of evidence can strengthen or weaken the balance, which is why the profile needs active management rather than a periodic check.

RMP Development and Maintenance

The Risk Management Plan (RMP) is the scientific document that intends to bring everything together concerning your product safety profile. This pivotal document maintains the overview of all risk, efficacy, and safety data. With our in-house regulatory, clinical development, and quality teams’ support at their disposal, our pharmacovigilance (PV) specialists manage the development of a high-quality RMP that meets all regulatory requirements and ensures its periodic updates.

Shortly, we help you set up your RMP to identify and distinguish drug product’s risks concisely and efficiently, leaving you with additional time to spend on your drug development or commercialization.

Risk Evaluation and Mitigation Strategies (REMS)

In the US, the Food and Drug Administration (FDA) can require a REMS for certain medicines with serious safety concerns. REMS share the same goal as RMPs, making sure a medicine’s benefits outweigh its risks, but they differ in structure and in when they’re required.

We support both, so portfolios spanning the EU and the US are handled consistently.