| RA profession | Introduction, role & responsibilities, Regulatory agencies | |
|---|---|---|
| ICH Quality guidelines | Analytical method validation, Stability, Impurities & Specification | |
| Genotoxic/ Mutagenic & nitrosamine impurities | ||
| ICH M4Q CTD guidance | Modules 1, 2, 3, 4 & 5, Bio-equivalence studies | |
| eCTD submissions, Regulatory inspections | ||
| India: CDSCO, Application types, procedures, SUGAM | ||
| Writing resume, facing RA interviews | ||
| API | DMF preparation | |
| USFDA | USDMF submission, review, changes to DMF | |
| Europe | EDQM, CEP submission, review, inspection, suspension, revision & renewal, ASMF submission | |
| Other markets | WHO, Canada, China submissions | |
| Formulation | Dossier preparation & regulatory filings: | |
| US: ANDA submission | Hatch-Waxman & patent certification rules, ANDA Modules, Labelling, ANDA submission and review, Approval process, Post approval changes | |
| Europe: MAA | EMA, HMA, Marketing authorization procedures, Patent scenario, Dossier- Modules, Variations | |
| Emerging markets [ROW submission] | Overview of procedures, COPP & FSC,labelling & artwork, agent or distributor, ACTD submissions | |