NOVO PROVIGILANCE LLC

Signal Detection Activities: Review, identification, processing, validating and taking appropriate action for the identified signal is very much necessary to analyze the continuous safety profile of the medicinal products available in the market. We have adroit subject matter experts for signal monitoring activity.

NOVO PROVIGILANCE signal detection process is performed by qualitative and quantitative methods.

The signal analysis threshold is calculated for the signal review period including identification of first-time events, adverse events of special interest, standardised MedDRA queries and concluding signal validity through case level assessment.

Signal report is prepared to define signal detection methodology and analyze the percentage of adverse events seriousness, reporter/report type criteria, causality criteria and expectedness of the adverse events in USPI, SmPC and Product Monographs.

Qualitative review of all adverse events including special case scenarios, literature review, clinical trial cases were discussed during current signal period. Any recommendations from Regulatory authority/Competent authority and or Pharmacovigilance Risk Assessment Committee (PRAC) shall be discussed and analyzed for the significant effect on safety profile of the product.

Risk Management: Special medicine safety plans may be required as part of a medicine’s approval process and to retain its approved status. We assist our clients in partial or complete preparation, review and finalization of USA risk evaluation and mitigation strategies (REMS) and REMS update reports; and compiles, writes and updates risk management plans (RMPs) for Europe.