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pathogen-variant-surveillance
Queries public GenSpectrum LAPIS data for pathogen genomic surveillance, current lineage nomenclature, weekly sequence proportions, reporting delays, and descriptive mutation frequencies. Use for variant surveillance, Pango lineage validation, dominant submitted lineages, Nextclade assignment provenance, SARS-CoV-2, influenza/H5N1 clades, RSV, mpox, measles…
isms-audit-expert
Information Security Management System (ISMS) audit expert for ISO 27001 compliance verification, security control assessment, and certification support. Use when the user mentions ISO 27001, ISMS audit, Annex A controls, Statement of Applicability (SOA), gap analysis, nonconformity management, internal audit, surveillance audit, or security certification p…
iso27001-audit-prep
/cs:iso27001-audit-prep <scope> — ISO 27001 ISMS audit readiness 6-question forcing interrogation. Use before annual Clause 9.2 internal audit, surveillance audit prep, or stage 1 certification readiness.
mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or g…
tooluniverse-adverse-event-detection
Detect and analyze adverse drug event signals using FDA FAERS reports, drug labels, and disproportionality statistics (PRR, ROR, IC). Generates quantitative safety signal scores (0-100) with evidence grading. Use for post-market surveillance, pharmacovigilance, drug safety assessment, regulatory submissions, and detecting rare AE signals not visible in clin…
tooluniverse-product-safety-surveillance
Post-market safety surveillance and recall/adverse-event RETRIEVAL across the full spectrum of FDA-regulated products that are NOT covered by the drug-AE signal skills: medical devices, food / dietary supplements / cosmetics, veterinary drugs, and drug supply (shortages). Orchestrates openFDA endpoints (MAUDE device adverse events + device recalls + 510(k),…
tooluniverse-adverse-event-detection
Detect and analyze adverse drug event signals using FDA FAERS reports, drug labels, and disproportionality statistics (PRR, ROR, IC). Generates quantitative safety signal scores (0-100) with evidence grading. Use for post-market surveillance, pharmacovigilance, drug safety assessment, regulatory submissions, and detecting rare AE signals not visible in clin…
tooluniverse-infectious-disease
Rapid pathogen characterization and drug repurposing for outbreaks. Combines pathogen genomics (NCBI, BVBRC), host immune response (IEDB), drug-target databases (ChEMBL, DGIdb), and literature surveillance (PubMed/EuropePMC). Use for emerging-pathogen profiling, antiviral candidate identification, and outbreak intelligence reporting.
tooluniverse-pharmacovigilance
Drug safety and adverse event analysis — FAERS spontaneous-report mining, FDA black-box warnings, signal detection (PRR, ROR, IC), risk factors by demographic/comorbidity, label change tracking, and SIDER curated label-derived side-effect frequencies. Use for post-market safety surveillance, AE signal investigation, drug-AE association strength scoring, "wh…
tooluniverse-product-safety-surveillance
Post-market safety surveillance and recall/adverse-event RETRIEVAL across the full spectrum of FDA-regulated products that are NOT covered by the drug-AE signal skills: medical devices, food / dietary supplements / cosmetics, veterinary drugs, and drug supply (shortages). Orchestrates openFDA endpoints (MAUDE device adverse events + device recalls + 510(k),…
tooluniverse-adverse-event-detection
Detect and analyze adverse drug event signals using FDA FAERS reports, drug labels, and disproportionality statistics (PRR, ROR, IC). Generates quantitative safety signal scores (0-100) with evidence grading. Use for post-market surveillance, pharmacovigilance, drug safety assessment, regulatory submissions, and detecting rare AE signals not visible in clin…
tooluniverse-infectious-disease
Rapid pathogen characterization and drug repurposing for outbreaks. Combines pathogen genomics (NCBI, BVBRC), host immune response (IEDB), drug-target databases (ChEMBL, DGIdb), and literature surveillance (PubMed/EuropePMC). Use for emerging-pathogen profiling, antiviral candidate identification, and outbreak intelligence reporting.
tooluniverse-pharmacovigilance
Drug safety and adverse event analysis — FAERS spontaneous-report mining, FDA black-box warnings, signal detection (PRR, ROR, IC), risk factors by demographic/comorbidity, label change tracking, and SIDER curated label-derived side-effect frequencies. Use for post-market safety surveillance, AE signal investigation, drug-AE association strength scoring, "wh…
tooluniverse-product-safety-surveillance
Post-market safety surveillance and recall/adverse-event RETRIEVAL across the full spectrum of FDA-regulated products that are NOT covered by the drug-AE signal skills: medical devices, food / dietary supplements / cosmetics, veterinary drugs, and drug supply (shortages). Orchestrates openFDA endpoints (MAUDE device adverse events + device recalls + 510(k),…
bio-epidemiological-genomics-amr-surveillance
Detects acquired antimicrobial-resistance determinants and chromosomal point-mutation resistance in bacterial assemblies using AMRFinderPlus, ResFinder 4.0 (acquired + PointFinder), CARD-RGI, abritAMR, staramr, and species-specific callers (TB-Profiler, Mykrobe). Harmonises cross-tool output via hAMRonization, contextualises determinants with mobile-genetic…
bio-epidemiological-genomics-variant-surveillance
Assigns pathogen lineages (SARS-CoV-2 Pangolin UShER mode; Nextclade clade + QC; pango-designation alias resolution) and tracks variant frequencies over time using Nextstrain (Augur + Auspice), wastewater deconvolution (Freyja, COJAC, alcov, lineagespot), lineage-fitness modelling (multinomial logistic), and recombinant detection (3SEQ, RDP4, Bolotie). Cove…
bio-workflows-outbreak-pipeline
Orchestrates genomic-epidemiology outbreak investigation from pathogen isolates to transmission networks, forking bacterial (snippy -> Gubbins recombination-masking -> IQ-TREE -> TreeTime -> TransPhylo) vs viral (Nextstrain/augur), with parallel MLST typing (cgMLST delegated to epidemiological-genomics/pathogen-typing) and AMR surveillance. Use when committ…
transfer-impact-assessment
Guides the post-Schrems II Transfer Impact Assessment process following EDPB Recommendations 01/2020 six-step methodology. Covers destination country surveillance law assessment, European Essential Guarantees evaluation, and supplementary measures determination. Keywords: TIA, transfer impact assessment, Schrems II, EDPB recommendations, supplementary measu…
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