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.

IGRS assign an expert for working on the risk management plan. The expert collaborates with the client to assess the risks, monitoring risk control, evaluating cost-benefit analysis.

IGRS provides support in writing risk management plan for pharmaceuticals dosage form intended for submission to Agency for approval. The periodic updates shall be monitored as per the received safety updates.

 

IGRS Expertise -

• Develop strategic and tactical plans to characterize and quantify safety concerns and minimize risks to patients.

• Customize risk management pharmacovigilance strategies to local requirements.

• Implementation of additional pharmacovigilance activities and risk minimization measures, including Post-authorization Safety Studies (PASS) such as observational studies and registries, creation of targeted questionnaires, and designing and implementing educational materials for pharmacovigilance risk management reporting.

• Design and implement interventions or studies that align with risk management pharmacovigilance and data collection objectives, and effectively implement these actions or studies in the post-marketing world.

• Revise and update the risk management pharmacovigilance document if warranted, as an outcome of the effectiveness evaluation.