Risk Management

EU Risk Management Plans (RMP) and US REMS Preparation and Submission Services

Pharmacovigilance Risk Management

When applying for a marketing authorization, all pharmaceutical companies should submit RMP (Risk management plan) to the European Medicines Agency (EMA) and similarly REMS (Risk Evaluation and Mitigation Strategy) for USFDA review and approval for certain drug or biological product to ensure that the benefits outweigh the risks.

An RMP is constantly modified and updated throughout the lifetime of the medicine as and when there is an important safety concern about a risk affecting the benefit-risk ratio or when new safety information becomes available from health authority or safety committee.

RMPs consists of the product safety profile along with concerned safety concerns (Important identified/ potential risk and missing information), their preventive and minimization measures (routine and additional) and how effectively they are implemented by measuring their effectiveness.

Pharmacovigilance Risk Management Services

iSafety provides companies with the following Risk Management and support services.

The core processes and services include:

  • Risk Management consulting for identifying, validating and segregating safety data into important identified, potential risk and missing information.
  • Risk Evaluation and Mitigation Strategies (US-REMS)-Preparation of communication plan, medication guide and other relevant safety data for REMS for effective implementation and timely submission
  • Risk Management Plan compilation (EU-RMP), analysis, medical evaluation and submission of annex1 in XML format in EudraVigilance via EudraLink RMP tool.
  • Routine and additional risk minimization activities in coordination with sponsors/MAHs and analysis of risk based on clinical overview and non-clinical study data.
  • Integration of Risk management activities into our periodic safety reports and our signal management protocols for assessing the benefit risk profile and quantifying the risk minimization measure efficiency based on the ICSR (Individual case safety report) data.
  • Post-marketing requirement studies like post-authorization safety studies (PASS)  
  • Observational studies, epidemiology studies and safety-surveillance studies
  • Risk minimization measure effectiveness assessment report.
  • Support MAHs/Sponsors in conducting additional pharmacovigilance activities which are mandate for few products (Ex:- compilation of targeted questionnaire for specific risk, pregnancy registry maintenance, etc)