Pharmacovigilance is a crucial science, which secures the unnecessary safety of drugs, once they enter the market. At the core of this is risk management, which is a preventive exercise that aids in identifying, analyzing, and reducing the risk involved in pharmaceutical products. Proper risk management does not only help safeguard patients but also keeps companies in regulatory and market appeals.
Our professional services at Masuu Global aim to support formulation and application of strong pharmacovigilance risk management approaches that suit your products and legal requirements.
What is Risk Management in Pharmacovigilance?
Risk management in pharmacovigilance is the identification of potential safety risks relating to a drug by a systematic process taking measures to address it. It involves gathering, evaluating, and reporting safety information during the lifecycle of the product.
It is aimed at maximization of therapeutic efficacy of a drug and at a reduction of its harmful effect on patients. The RMP is a dynamic document that should be updated throughout the life cycle of the product(s). This includes the addition of safety concerns where required, but also, as the safety profile is further characterised, the removal or reclassification of safety concerns.
Responsibilities for risk management
An applicant/marketing authorisation holder is responsible for: Having an appropriate risk management system in placeEnsuring that the knowledge and understanding on the product’s safety profile, following its use in clinical practice, are critically reviewed. The marketing authorisation holder should monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the risk-benefit balance of medicinal products and update the risk management system.
Key Elements of Pharmacovigilance Risk Management
- Risk Identification: Collection of safety data collected during clinical trials, post marketing surveillance, literature monitoring, spontaneous reports to identify known and potential risks.
- Risk Assessment: Assessment of the intensity, prevalence, and effect of the recognized risks in the various groups of patients.
- Risk Minimization: Developing controls to minimize the frequency or severity of risks, and which could involve revised labelling, restricted use, more specific communication to medical staff, or more supervision.
- Risk Communication: Making healthcare professionals, regulators and citizens aware of the dangers and what had been done to control the same.
- Risk Evaluation: Monitoring the effectiveness of risk minimization efforts and making changes continuously.
Risk Management Plans (RMPs)
The Risk Management Plan (RMP) is an important instrument in risk management of pharmacovigilance and is mandatory in many regulatory agencies including the European Medicines Agency (EMA). RMP describes known and possible risks, planned pharmacovigilance, and risk minimisation steps.
The RMP is a dynamic document that is modified by updated safety information and governmental response, facilitating quality decision making and regulatory health
Regulatory Framework
Risk management is a key requirement of regulators globally in their pharmacovigilance expectations. Key guidelines include:- ICH E2E Pharmacovigilance Planning
- EMA Good Pharmacovigilance Practices (GVP) Module V (Risk Management Systems)
- FDA Risk Management and Mitigation Strategies (REMS)
- Failure to adhere to risk management requirements may have severe outcomes like regulatory actions or product recall.
The Role of Masuu Global in Pharmacovigilance Risk Management
Masuu Global has an end-to-end solution of pharmacovigilance risk management, which covers:- Risk Management Plans (RMP) Development and maintenance
- Safety signal detection and evaluation
- Design and implementation of risk minimization measures
- Monitoring literature and analysis of ICSR to determine potential risks
- Writing of regulatory submissions and updates
- Compliance and training audit
- Our professionals guarantee that your risk management plan is proactive, adaptive, and certifying to new regulations that might emerge.
Pharmacovigilance would be incomplete without risk management, which keeps medicines safe and efficacious to patients across the globe. You are capable of managing risks associated with products, staying compliant and producing better patient outcomes with the help of Masuu Global expertise.
Contact us here to find out how our personalised risk management service can assist your pharmacovigilance program.
