Safety and pharmacovigilance are key to medical product longevity, consumer confidence, and regulatory compliance.
Risk Evaluation and Mitigation Strategies (REMS) manage known or potential serious risks associated with a drug, vaccine, biologic, or medical device. Our REMS and protocol-specific pharmacovigilance plans ensure that when risks are identified, they are prevented or mitigated adequately. TRI´s pharmacovigilance plans include data mining and safety data analysis, signal detection and evaluation reports, safety alerts and safety distributions to ensure the risks of the drug—known, potential, and unknown—are captured and communicated. In addition to designing strategies and plans for product safety, we create company core data sheets, risk-related position papers, literature review and summaries, and drug safety gap analysis. Our Pharmacovigilance team follows the ICH guidelines for drug safety and pharmacovigilance, the FDA´s Good Pharmacovigilance Practices, and EMA´s European Directive 2001/20/EC.
- Risk Evaluation and Mitigation Strategies (REMS) and protocol-specific Pharmacovigilance Plans
- Data mining and safety data analysis
- Signal detection and signal evaluation reports
- Safety alerts and safety distributions
- Company core data sheets
- Investigator’s Brochures
- Package Inserts
- Adverse events expectedness lists
- Risk-related position papers
- Literature reviews and summaries
- Drug safety gap analysis