GAP begins a risk management program with classification and evaluation of risks related to the products. GAP works with sponsor to expand different goals related to the reduction of risk via execution of various risk management plans. GAP team will help sponsor to actively monitor, review, the risk profile of different products and provide metrics to evaluate the results and efficiency of various risk management plans. FDA requires Risk Evaluation and Mitigation Strategies (REMS) of the product; REMS is an approach which is implemented to handle an identified or probable serious risk related to the products. If any product does not meet the requirement, GAP will provide guidance and helps to improve.
GAP’s Risk Management Services includes:
Improvement of Risk Minimization Plan (RMP)
Pharmacovigilance plan, Reference Safety data (e.g. SmPC, PI, CIB, CCSI) audit/modification yearly Risk Assessment and Communication Plan
Medication Guide and Patient Package Insert
Therapeutic evaluation of aggregate reports, Position papers, Safety peril investigation, Case account organization evaluation/clinical assessment remarks, Causality evaluations and Danger profit evaluations
Mechanisms to limited use of the product
Review of Adverse events of special interests (AOSE), Incorporated Summary of Safety Sections (ISS), New Drug Application(NDA) yearly report
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