Regulatory Informatics & Chemical Safety — Hands-on

Build confidence in regulatory informatics & chemical safety for discovery and development. This hands-on module operationalizes REACH/CLP & GHS classification, ICH M7 impurity assessment, QSAR & read-across justifications, exposure/risk characterization, and IUCLID/SDS documentation. Ship a dossier-ready evidence pack with transparent assumptions and provenance.

Regulatory Informatics & Chemical Safety (REACH / ICH)

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Session Index

Session 1 — Frameworks, Hazard Classes & Data Session 2 — QSAR, Read-Across, TTC & Alerts Session 3 — Exposure, Risk & Documentation Session 4 — Mini Capstone: Dossier & SDS Pack

Session 1

Fee: Rs 20800

Frameworks, Hazard Classes & Data Foundations

Regulatory landscape

REACH/CLP (EU) GHS & SDS ICH M7 (mutagenic impurities)

Hazard classification & endpoints

acute/chronic tox, CMR sensitization/irritation env hazards (aquatic)

Data & evidence

OECD TGs & study quality (KLIMISCH) IUCLID fields & attachments provenance & audit trail

Session 2

Fee: Rs 23800

QSAR, Read-Across, TTC & In Silico Alerts

QSAR best practices

model validity & AD uncertainty & calibration documentation for regulators

Read-across & weight-of-evidence

structural analogs & justification category formation IATA decision trees

TTC & alerting

TTC bands (Cramer) mutagenicity alerts (ICH M7) OECD QSAR Toolbox / VEGA / Toxtree

Session 3

Fee: Rs 26800

Exposure, Risk Characterization & Documentation

Exposure scenarios & controls

worker/consumer/environment use descriptors release estimates

Risk characterization

DNEL/DMEL derivation RCR calculations PBPK-lite considerations

Documentation & submissions

IUCLID sections SDS authoring (16 sections) labeling & pictograms (GHS)

Session 4

Fee: Rs 30800

Mini Capstone: Mock Dossier & Safety Pack

Assemble an evidence-based submission (hazard → exposure → risk)

Theory + Practical

Outputs for review & audits

classification & label elements SDS (16 sections) + annex IUCLID export & rationale

Deliverables

mock dossier bundle (ZIP) SDS PDF + label assets assumptions & AD report

Note: Training outputs are instructional and do not constitute legal submissions or regulatory advice.

PDF

Regulatory Informatics & Chemical Safety (REACH/ICH) | QSAR, Read-Across, Exposure & SDS

Regulatory Informatics & Chemical Safety — Hands-on