Risk Management and Risk Minimisation
We support the development and implementation of global and local risk-management strategies for both investigational and marketed products.
Services include:
- Design of routine and additional pharmacovigilance activities
- Identification and characterisation of important identified risks, important potential risks and missing information
- Strategic medical input into Risk Management Plans
- Development and maintenance of safety specifications and pharmacovigilance plans
- Development and implementation of risk-minimisation measures
- Preparation of educational materials and implementation plans
- Support for EU additional risk-minimisation measures
- Medical input into US Risk Evaluation and Mitigation Strategies
- Support for local affiliate discussions with national health authorities globally for implementation of risk management activities
- Evaluation of the effectiveness of pharmacovigilance and risk-minimisation activities
- Alignment of risk-management documentation with product information and the evolving safety profile
Experience includes complex EU Risk Management Plans, extensive US REMS programmes, Phase IV studies, observational safety studies and patient registries.