Industry Program in Regulatory Affairs in Pharmaceutics (PRAP)
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Short Course by
Glorious Institute Of Pharma and Bioinformatics
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Details
Pharmaceutical Regulatory Affairs is considered to be a crucial department within the pharmaceutical companies, mainly because they deal with new clinical trial applications, new product marketing applications and regularly
interact with the regulatory agencies to ensure that the company is compliant to applicable regulations and is fulfilling all its regulatory obligations.
COURSE OBJECTIVES:
There are many regulations in place so that manufacturing pharmaceutical products, veterinary medicines, therapeutic devices, and many others is effective so as to be able to provide sustainable healthcare to individuals. A pre-requisite of pharma regulatory affairs as a profession is to possess thorough knowledge of all the major regulatory authorities such as the US FDA, EMA, DCGI etc and a know how / training of working in compliance with their regulations.
COURSE ELIGIBILITY: The eligibility for the introductory program is 10+2.
CORSE FEE: The Course Participation Fee for this program is Rs. 10,500 for participants based in India / USD 325 for Overseas participants.
Outline
- Introduction to judicial system in india ,D&C Act
- Indian regulations governing clinical trials
- Regulatory regime –FDA,EMA, JAPAN
- Safety topics related to preclinical clinical studies
- CMC Information &GHTF Overview
- Biopharmaceutical Indian regulations and regulatory strategic Planning
Schedules
Jan 18, 2018 - Nov 30, 2018
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| No. of Days: | 220 |
| Total Hours: | 220 |
| No. of Participants: | 25 |
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Established in 2014 , Glorious Institute of Pharma & Bioinformatics (A Unit of Glorious Confrere Educational & Industrial Institution) is, vision, mission and career improvement strategy commited to provide world class technical and scientific education in Pharma, Life Science (Biotech and Bioinformatic) domain via Distance Learning (Correspondence)
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