Comprehensive Program in Regulatory Affairs for Pharmaceutics [12 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
12 Months
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Start date
Different dates available
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Delivery of study materials
Yes
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Support service
Yes
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Examinations- physical attendance required
Yes
This course will help them understand the fundamental and concepts of regulation prevailing in various countries. It will enhance their knowledge and skills in the field of Regulatory affairs. The objectives of the course are: To create experts in the field of RA documentation and research. To encourage continuous learning and development in RA field. To update knowledge of existing RA professionals. Suitable for: B Pharmacy/ M Pharmacy/ Science Graduate with working Experience
Facilities
Location
Start date
Start date
About this course
The courses will provide integrated knowledge and broad perspectives you need to effectively manage the regulatory process from Innovation →Discovery → Approval→ Commercialization which implies regulatory affairs are essential to bring the product to the market globally.
To gain the essential knowledge and skills required to help companies to work in regulatory environment.
To acquire the foundation to work within or in variety of areas including medical products development, pharmaceutical formulations, sales, strategic marketing and clinical investigations.
To know about regulatory process in drug development, formulations, API.
To sharpen the understanding of the laws that governs the development, manufacturing and commercialization along with the distribution of drugs, biologics and medical devices.
This course is aimed at participants who want to join Regulatory Affairs as career.
Post Graduate in Life-science or Pharma OR Graduate in Life-science with work experience in similar domain.
Post Graduate in Life-science or Pharma OR Graduate in Life-science with work experience in similar domain.
This program will upgrade you to enter or promote in Regulatory Affairs domain.
After receiving your request our team member will contact you and mail you all related information.
Reviews
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Course is helpful to get DRA entry level job
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Course rating
Recommended
Centre rating
Anjukrishna S R
Subjects
- Regulatory Compliance1
1 students say they acquired this skill
- Regulatory Affairs
11 students say they acquired this skill
- DRA
11 students say they acquired this skill
- FDRA
11 students say they acquired this skill
- RA
11 students say they acquired this skill
- DMF
11 students say they acquired this skill
- Dossier
11 students say they acquired this skill
- Pharma Regulatory Affairs
11 students say they acquired this skill
- Regulatory Compliances and Affairs
11 students say they acquired this skill
- Drug Safety
11 students say they acquired this skill
- Drug Laws
11 students say they acquired this skill
Teachers and trainers (3)
Dr Abhinav Srivastava
Biotechnology
Dr. Kumud Sarin
Technical Head
Mr. Ajay Viswakarma
Bioinformatics
Course programme
Here is the course papers
Paper-I: Introduction to Regulatory Affairs and Profession
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
Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH Guidelines
Paper-VI: Regulatory Strategy and Quality Assurance Systems
Paper-VII: Future of Biopharmaceuticals
Paper-VIII: Research StudyComprehensive Program in Regulatory Affairs for Pharmaceutics [12 Months]
₹ 14,500 VAT incl.Add similar courses
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