Risk Management Services

The primary purpose of Risk Management Plans is to provide guidance to identify, minimize, and monitor patient safety risks. It is mandatory for all Marketing Authorisation Holders to provide a comprehensive and detailed risk management plan in the EU. A risk management document will manage and minimize the risk of potential and known safety issues. We at Vizen life science will provide you with complete risk management services that include review, maintenance, risk minimization measures like observational studies, targeted questionnaires creation, registries, design, and implementation of educational materials for risk minimization. The risk management plans include all the information related to the drug’s safety profile and also plans for the pharmacovigilance activities such as how risks will be minimized, and how the efforts will be measured.

Our Services

Vizen life sciences expertise in risk management services includes evaluation of the requirements, Preparation of the required documents as per the REMS (Risk Evaluation and Mitigation Strategies) program meetings, Preparation of important elements of REMS like Communication Plan, Patient Package Insert or Medication Guide, Elements to Assure Safe Use (ETASU) and its Implementation System, Sharing information relating to REMS program meeting at agreed time intervals, Play an important role in compilation and preparation of REMS report, Handling issues and queries related to REMS data, Inclusion of REMS assessment timetable, assistance on feedback/updates shared by the FDA, provide support until REMS approval, Customize the risk management strategies according to local requirements, Develop strategic plans to characterize, quantify, and minimize risks to patients, Implement additional Pharmacovigilance activities, and revise & update the risk management plans as per the client needs, etc.

Why Vizen Life Sciences?

The requirement of a Risk Management Plan will depend on the nature of the variation and it may not be absolutely necessary in case of all circumstances. The Vizen life sciences pharmacovigilance risk-benefit experts, medical writers, and healthcare professionals will advise you on both the need for a risk management plan and its contents. We will help our clients in determining the important potential and already identified risks for both the abbreviated and detailed risk management plans. Vizen life sciences have experience in assessing risk-benefit analysis, writing Risk Management Plans, Maintaining Risk Management Plans, Advising the risk minimization measures, and measuring the effectiveness of the minimization activities.