Advanced Diploma in Drug Regulatory Affairs (ADDRA) offered by Jamia Hamdard University - Extension Center
Advanced Diploma in Drug Regulatory Affairs (ADDRA) at Jamia Hamdard University - Extension Center Overview
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
at Jamia Hamdard University - Extension Center
Equip you with a specialized skillset for navigating the complex world of drug regulations
Duration | 12 months |
Total fee | ₹24,500 |
Mode of learning | Online |
Official Website | Go to Website  |
Credential | Certificate |
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
Table of content
- Overview
- Highlights
- Course Details
- Curriculum
- Entry Requirements
Advanced Diploma in Drug Regulatory Affairs (ADDRA) at Jamia Hamdard University - Extension Center Highlights
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
at Jamia Hamdard University - Extension Center
- Earn a diploma from Jamia Hamdard University
- Fee payment can be done in instalments
- Learn from industry experts
Advanced Diploma in Drug Regulatory Affairs (ADDRA) at Jamia Hamdard University - Extension Center Course details
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
at Jamia Hamdard University - Extension Center
Skills you will learn
Who should do this course?
- For individuals who want to enhance their knowledge & skills in the field
What are the course deliverables?
- Gain a comprehensive understanding of the regulatory frameworks governing drug development, registration, and marketing approval in different regions, including key regulatory bodies like the US FDA, EMA (Europe), and ICH (International Council for Harmonisation)
- Develop in-depth knowledge of relevant national and international drug regulations, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP)
- Master the intricacies of the drug registration process, including dossier preparation, data compilation, and communication with regulatory agencies
- Develop strong skills in writing and compiling regulatory documents such as Common Technical Documents (CTD) and electronic Common Technical Documents (eCTD) for marketing authorization applications
- Learn how to develop effective regulatory strategies to ensure smooth drug development, registration, and market access
More about this course
- The main objective of this Programme is to provide an interdisciplinary knowledge of pharmacy and law as applicable in the field of pharmaceutical regulation at national and international levels
- The course prepares the students to pursue career in pharmaceutical industry, drug licensing and control authorities, and export- import agencies dealing with the pharmaceuticals
Advanced Diploma in Drug Regulatory Affairs (ADDRA) at Jamia Hamdard University - Extension Center Curriculum
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
at Jamia Hamdard University - Extension Center
An Introduction to Pharmaceutical Drug Regulatory Affairs
General Pharmaceutical Laws and Guidelines
Drug Regulatory Affairs in India
Information and Quality Management
Chemical, Pharmaceutical and Biological aspects of Regulatory Documentation
Clinical Trials and Health Care Policies
International Licensing
Regulatory Considerations in Controlled Drug Delivery and Future Aspects of Biopharmaceuticals
Advanced Diploma in Drug Regulatory Affairs (ADDRA) at Jamia Hamdard University - Extension Center Entry Requirements
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
at Jamia Hamdard University - Extension Center
Eligibility criteria
- Education: B. Pharma / MBBS / BUMS or a Bachelor Degree in Science from a recognized University
Other courses offered by Jamia Hamdard University - Extension Center
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
at Jamia Hamdard University - Extension Center
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at Jamia Hamdard University - Extension Center
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Advanced Diploma in Drug Regulatory Affairs (ADDRA) at Jamia Hamdard University - Extension Center Contact Information
Advanced Diploma in Drug Regulatory Affairs (ADDRA)
at Jamia Hamdard University - Extension Center
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11, First Floor ,opp Metro Pillar No 118
Landmark: Opp. Shanti Mukund Hospital
Delhi
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