Benefit-Risk Management

Addressing uncertainties in the safety profile at different timepoints of the product lifecycle, and planning accordingly, ‘go for the jugular’ in any Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS). At PrimeVigilance we recognize that the benefit-risk profile (B:R) is a dynamic process pre-, peri- and post-approval and we have marshalled our troops to this effect.

Our PV experts lead or support your risk management planning in both the pre-approval and post-market settings. PrimeVigilance can navigate you through the development of Risk Minimization Measures (RMM) with an implementation scheme, specific tool recommendation and an evaluation strategy.

While routine risk minimization measures apply to every medicinal product once registration is granted, when considered essential for the safe and effective use of a medicinal product/medical device, additional RMM may be required.

Our international team, based in Europe, N. America and Asia, will:

• Review or prepare educational materials, pregnancy prevention programs, controlled access programs and Direct Healthcare Professional Communications (DHPCs)
• Align your risk mitigation processes across multiple geographies. We strive to streamline RMP amendments/variations and submissions, especially for centrally authorized products (CAPs) or for authorized products with unique regional requirements; e.g., differing biovigilance responsibilities for sponsors in Canada, Australia and Europe
• Keep a track record of recommendations from PRAC, EMA, National Competent Authorities and Product-specific Guidance (PSGs), so our medical writers are able to produce a joint draft RMP or parallel RMPs timely to facilitate assessment by regulatory agencies.

For the benefit side of the B:R, new aspects are becoming increasingly important such as lifestyle considerations, Quality of Life (QoL) aspects, meaningful patient engagement and electronic patient-reported outcomes (ePROs) and electronic clinical outcome assessments (eCOA). Regarding risks, our team will examine background co-morbidities, patient core values and lifestyle considerations at both a population and individual level for medicines used in the ‘real world’.

Our PV physicians and medical writers perform overall appraisals of the B:R of medicinal product(s) as used in clinical practice and in ‘real world’. Based on the evaluation of the safety data and the associated risk-benefit analysis, we can propose changes and/or actions for further discussion with regulatory authorities.