Certificate in Regulations for Biologics and Pharmaceutical Product.[6 Months]
Course
Distance
Description
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Type
Course
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Level
Advanced
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Methodology
Distance learning
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Duration
6 Months
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Start date
Different dates available
IBRI provide the understanding of the laws that governs the development, manufacturing and commercialization along with the distribution of drugs, biologics and medical devices.Regulatory Affairs is the area with a broad overview and the responsibility for collecting all data from the development processes and sending it to regulatory authorities where the trained people in regulatory affairs is required.
Facilities
Location
Start date
Start date
About this course
Any science graduate or having experience in similar industry.
On receiving your request, our academic cell will contact you by mail, phone or Whats app.
Reviews
Subjects
- Regulatory Affairs
- Regulatory Compliance
- Regulation Law
- Dossiers preparation
- DMF
- DMF submission
- Licensing Affairs
- Documentation
- Drug Laws
- Efficacy of products
Teachers and trainers (3)
Dr Abhinav Srivastava
Biotechnology
Dr. Kumud Sarin
Technical Head
Mr. Mithilesh Mishra
Information Technology
Course programme
Certificate in Regulations for Biologics and Pharmaceutical Product.[6 Months]
Paper-I: Introduction to Regulatory Affairs
Paper-II: International Licensing and Drug Regulatory Affairs
Paper-III: Regulatory Documentation for Biologics/Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc)
Paper-IV: Global Regulatory Compliance Systems
Certificate in Regulations for Biologics and Pharmaceutical Product.[6 Months]