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