Developing an efficient risk management system for proactive risk assessment and continued safety surveillance

Every therapeutic modality has associated risks. These risks, if not managed well, can pose threat to patient safety or even public health, and regulators take this very seriously. Regulators have mandated proactive risk assessments and continuous safety surveillance for therapeutic products throughout their life cycle. An efficient risk minimization system lays out a systematic platform on which the pharmacovigilance plan and risk–benefit analysis is characterized for any drug.

The APCER Risk Management team provides strategic advice and analysis; develops the US risk evaluation and mitigation strategies (REMS) and REMS update reports; and compiles, writes, and updates risk management plans (RMPs).

The team supports customers in the following specialized activities:

• Additional Risk Minimization Measures (aRMM) implementation including drafting of educational materials; educating/training the HCPs and, setting up a drug and/or Patient registries e.g. (pregnancy registry), on a web-based HCP and patient registration portal
• Medical information call center (MICC) support to the implementation of aRMM to handle enrolment queries, ADR/pregnancy reporting and follow ups
• aRMM tracking and effectiveness assessment
• Supports consortium
• Targeted follow-up questionnaires (TFUQs)
• Periodic review
• MAH/Applicant support for oversight process build-up
• Stakeholder/Local affiliate training
• Handholding in implementation and risk group committee workshop