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). We recognize that the benefit-risk profile 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. We navigate you through the development of Risk Minimization Measures (RMM) with an implementation scheme, specific tool recommendation(s) and an evaluation strategy.

Our international team, strategically distributed in Europe, N. America and Asia:

• 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 requirements in Canada, EU and Asia Pacific
• Keep a track record of recommendations from PRAC, EMA, National Competent Authorities and Product-specific Guidance (PSGs) as per GDUFA III for generic drug product development, so our medical writers are enabled to prepare well timed joint draft or parallel RMPs.

New aspects are becoming increasingly important in the evaluation of benefit-risk profile, such as lifestyle considerations, new types of therapies such as ATMPs and digital therapeutics, Quality of Life (QoL) parameters, meaningful patient engagement, electronic patient-reported outcomes (ePROs) and electronic clinical outcome assessments (eCOA). Our team will also examine background co-morbidities, patient core values and lifestyle considerations at both a population and individual level for medicines used in ‘real world’.

• Our PV physicians and medical writers perform overall appraisals of the benefit-risk of medicinal product(s) as used in clinical practice and in ‘real world’. Using evidence and insights from RWD, we monitor new treatments for safety including effectiveness of RMMs. Based on this evaluation, we propose RMMs changes or actions.
• Our multidisciplinary team will assist you during safety referral and Art 5.3 review procedures, as per articles 107i and 31PhV of Directive 2001/83/EC and article 20PV of Regulation (EC) 726/2004 in the EU.
• Our teams of physicians and medical writers will assist you during the PSUSA procedure in collaboration with Ergomed’s Regulatory Affairs team who can advise you on regulatory actions e.g., submission strategy of post-authorization measures (PAMs) for CAPs.