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Regulatory Services in South AfricaMedical literature, including literature review in research, is one of the primary sources of safety data. As regulations become increasingly stringent MAHs are presented with challenges in incorporating safety data into their pharmacovigilance practices for compliance. Therefore, regular monitoring of scientific literature is key for timely identification of ICSRs that not only helps in fulfilling the safety compliance, but also helps in including the relevant safety information in aggregate reports for timely completion and in identifying the signals. Drawbacks or errors in these processes can negatively affect the pharmacovigilance compliance by MAH & may lead to adverse audit/inspection findings.
DDReg offers specialized and comprehensive literature monitoring and surveillance services to organizations. Our team works to ensure that there is no compromise in identifying & processing the literature ICSRs and/or safety signals. DDReg literature surveillance team has expertise in devising comprehensive search strategies, carrying out review of weekly outcomes from literature databases such as PubMED or EMBASE and triaging & booking the cases that are identified.
DDReg’s Literature Monitoring expertise includes:
- Weekly monitoring of publications in different databases such as Embase, PubMed or Medline
- Weekly monitoring of ICSRs received as through Medical Literature Monitoring (MLM) or Anonymized Single Patient Reports (ASPRs)
- Devising comprehensive literature search strategy for weekly outcome from PubMED &/or EMBASE
- Documentation of outcomes using abstract or full text articles that assist in identifying ICSRs,
- Maintaining the complete tracking of literature cases based on Validity,
- Use in Aggregate reports and PSUR/ RMP
- Use in identifying the signals
