Comprehensive Program in Regulatory Affairs for Pharmaceutics
Course
Online
Description
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Type
Course
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Level
Advanced
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Methodology
Online
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Duration
6 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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Virtual classes
Yes
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
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.
Post Graduate in Life-science or Pharma OR Graduate in Life-science with work experience in similar domain.
Reviews
Subjects
- Regulatory Affairs
- Regulatory Compliance
- DRA
- Pharma
- Pharmacist
- Pharmacology
- Pharmacy Technician
- Marketing Agency
- Pharmacy Assistant
- Pharmaceutical manufacturing
Teachers and trainers (1)
Dr. Shikha Mishra
Regulatory affairs
Course programme
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 Study
Comprehensive Program in Regulatory Affairs for Pharmaceutics