We appraise the benefit-risk profile of your products as used in clinical practice and provide solutions towards filling in the knowledge gaps in RMPs to facilitate development of medicines for older people.
Our SMEs can assist you to build or to adjust your risk management plans (RMP) prior to product registration and during assessment should PV activities concerning aspects such as co-morbidities and the monitoring of specific side effects associated with older patients be requested or discussed during MAA/licensure evaluation or as part of a supplemental new drug submission (SNDS) associated with expanded target population such as older patients.
- For organizations which are instructed to perform post-market benefit-risk assessments, our PV experts appraise the benefit and risk profile of the product as used in clinical practice and provide solutions towards filling in the knowledge gaps through: post-authorization studies, incl. patient registries, targeted RMMs, e.g., educational tools, controlled distribution systems, DHPCs, additional monitoring of certain medicines.
- Where enrolment of geriatric patients during clinical development has been insufficient, our experts can advise you on plans to collect data post-marketing and how they should be presented in marketing application as per ICH E7 in collaboration with our medical writers.
- 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, keeping in mind the (anticipated) geriatric information that will be inserted in the product labeling.
