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Distance Participation Programs |
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Procedure :- |
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Prospective participants join the program by submitting admission form, photograph, Graduation/Post-graduation certificate, resume and fees. |
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Fees to be paid in at par cheque/Demand draft in favour of ‘Institute of Pharmaceutical Management’ (payable at Thane). |
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Course will commence after admission formalities are completed. |
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Students will receive the notes (at the postal address mentioned on the admission form) according to schedule. |
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Notes (prepared by experts, contain the latest information on the subject) and a set of questions related to the topic will be given to the students. Students will answer the questions (Self Assessment questions), to gain expertise on the topics |
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Candidates are requested to mail their queries related to the subject; these will be answered within 15 working days. |
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Telephonic interviews / Interviews at site (50 marks) will be conducted at the end of the course |
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Question paper (50 marks) will be sent to students, answers will be evaluated. |
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Successful students will be awarded ‘Diploma in the respective areas’ by Distance participation along with the grade obtained. |
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1.Distance Participation Programme for ‘Diploma in Drug Regulatory Affairs’ : |
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Working professionals/ B.Pharm /M.Pharm / M.Sc / B.Sc with minimum 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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8 months |
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2.Distance Participation Programme in Pharma Quality Management : |
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Working professionals/ B.Pharm /M.Pharm / M.Sc / B.Sc |
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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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6 months |
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