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Classroom training courses: |
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1. Post - Graduate Diploma in ‘Drug Regulatory Affairs ’ (API & Formulations) |
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Working professionals/ B.Pharm /M.Pharm / M.Sc / B.Sc with one year industrial experience. |
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Introduction to RA profession |
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ICH Quality guidelines |
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DMF preparation in CTD format |
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API-Regulatory submissions to USFDA, EDQM & EMEA |
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API-Regulatory submissions to WHO, Brazil, Canada and Japan |
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Formulation development, pre-formulation studies & reverse engineering |
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Patents from regulatory perspective |
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Dossier preparation in CTD format |
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Regulatory Systems in US, ANDA submissions, handling post approval changes |
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Regulatory Systems in Europe, filing procedures, handling variations |
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Drug Registration with semi-regulated countries |
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Handling deficiencies from Drug Regulatory Authorities |
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Facing GMP audits and regulatory inspections |
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eCTD submissions |
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2. Diploma in ‘Drug Regulatory Affairs- Formulations’ |
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Working professionals/ B.Pharm /M.Pharm / M.Sc |
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Introduction to RA profession |
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ICH Quality guidelines |
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Formulation development, pre-formulation studies & reverse engineering |
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Patents from regulatory perspective |
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Dossier preparation in CTD format |
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Regulatory Systems in US, ANDA submissions, handling post approval changes |
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Regulatory Systems in Europe, filing procedures, handling variations |
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Drug Registration with semi-regulated countries |
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Handling deficiencies from Drug Regulatory Authorities |
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Facing GMP audits and regulatory inspections |
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eCTD submissions |
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Practical experience of preparing Dossier |
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3. Diploma in ‘Drug Regulatory Affairs- API’ |
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Working professionals/ B.Pharm /M.Pharm / M.Sc / B.Sc with one-year industrial experience. |
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Introduction to RA profession |
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ICH Quality guidelines |
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DMF preparation in CTD format |
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API-Regulatory submissions to USFDA, EDQM & EMEA |
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API-Regulatory submissions to WHO, Brazil, Canada and Japan |
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Patents from regulatory perspective |
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Handling deficiencies from Drug Regulatory Authorities |
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Facing GMP audits and regulatory inspections |
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eCTD submissions |
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Practical experience of preparing DMF |
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4. Diploma in ‘Pharma Quality Management’ |
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Working professionals/ B.Pharm /M.Pharm / M.Sc / B.Sc with one-year industrial experience |
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Pharmaceutical Quality system |
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Chromatographic techniques |
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ICH quality guidelines |
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Material Management |
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Documentation control |
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Production and Laboratory Control |
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Qualification and Validation |
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Change Management system |
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Market Complaints and recalls |
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GMP audits |
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5. Diploma in ‘Pharma Quality Operations and Regulatory Affairs’ |
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B.Pharm /M.Pharm / M.Sc / B.Sc undergraduates and graduates |
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Overview of Pharmaceutical Quality System |
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Regional GMP requirements |
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Pharma process flow from receipt of material to dispatch of product |
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Various pharmacopoeias: Introduction and usage |
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Documentation: Creation, Review, Approval, Distribution etc |
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Analytical techniques and applications in Pharma industry |
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Material : Sampling, testing, release and rejection |
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Discussion on monographs |
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Introduction to ICH Quality Guidelines |
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Validation approach |
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Handling Change control and deviations |
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Facing audits |
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Registration procedures of various regulatory agencies – US, Europe, WHO |
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DMF and dossier preparation in CTD format |
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6. Diploma in ‘Clinical Research and Pharmacovigilance’ |
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Working professionals/ B.Pharm /M.Pharm / M.Sc / B.Sc |
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Introduction to clinical research & Phases in Clinical Research |
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ICH-GCP |
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Schedule Y |
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Introduction to Pharmacovigilance |
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Regulatory aspects in Pharmacovigilance |
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Drug Safety in Clinical trials |
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WHO guidance and National Pharmacovigilance Programme |
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Safety reporting Requirements in Post-authorization Phase |
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Setting up of a Pharmacovigilance Department |
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Preparation of Periodic Safety Update Reports |
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Management of Pharmacovigilance Data |
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Signal Detection |
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MeDRA coding |
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Causality Assessment |
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Quality System in Pharmacovigilance : Good Pharmacovigilance Practice, SOPs, Preparation for Audits & Inspections |
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Pharmacoepidemiology |
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7 Diploma in ‘Patent Laws’ |
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Technically qualified graduates or Post graduates (Science/ Engineering
back-ground) |
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Introduction to IPR and Patents |
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International treaties |
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Definitions and content of Patent systems |
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Indian Patent laws |
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US and Europe Patent regime |
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Patent laws –Rest of World |
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Enforcement, Exploitation and Abuse of Patents |
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Patent drafting, Litigation and Enforcement with case-laws discussion |
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Commercialization and licensing |
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Search for prior art for various Patent systems |
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Patent opposition with examples |
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