Advanced Diploma In Drug Regulatory Affairs
4.0 /5- Offered byElite Institute Pharma Skills
Advanced Diploma In Drug Regulatory Affairs at Elite Institute Pharma Skills Overview
Duration | 6 months |
Total fee | ₹12,000 |
Mode of learning | Online |
Official Website | Go to Website  |
Credential | Certificate |
Advanced Diploma In Drug Regulatory Affairs at Elite Institute Pharma Skills Highlights
- Earn a diploma upon completion of course
Advanced Diploma In Drug Regulatory Affairs at Elite Institute Pharma Skills Course details
Individuals already working in regulatory affairs who seek to deepen their knowledge of global regulatory processes and stay updated on industry standards and changes in regulations
Students with backgrounds in pharmacy, chemistry, biology, biochemistry, or related fields looking to pursue a career in regulatory affairs or the pharmaceutical industry
An overview of the field of regulatory affairs, its role in the pharmaceutical industry, and its importance in the global healthcare system
Understanding the regulatory responsibilities after a drug is approved, including post-marketing surveillance, adverse event reporting, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)
The Drug Regulatory Affairs course provides comprehensive knowledge of the regulatory processes involved in the development, approval, and marketing of pharmaceutical products
This course is designed for individuals interested in pursuing a career in pharmaceutical regulation, providing an understanding of the key regulations, standards, and policies that shape drug approval and distribution in global markets
Advanced Diploma In Drug Regulatory Affairs at Elite Institute Pharma Skills Curriculum
Introduction to Regulatory Affairs
Purpose & principle of Regulations
The Legal Framework for Regulations
Guidance Document on Regulatory Affairs
Drug regulatory and accrediting agencies of the world
ISO
WHO
US FDA
ICH
EDQM/EMEA
MHRA (UK)
TGA
Health Canada
Regulatory Document
Common Technical Document (CTD)
Electronic Common Technical Document (eCTD)
Asian Common Technical Document (ACTD)
Country Specific Dossiers
Detailed study of other supportive documents
Non Clinical Study Reports (M4S)
Pharmacology Written and tabulated Summary
Pharmacokinetics Written and tabulated Summary
Toxicology Studies
Clinical Trials (E3)
Clinical Trial Design
Independent Ethics Committee (IEC)
Good Clinical Practice
Patient information and Consent
Investigational plan and study protocol
Efficacy and Safety Evaluation
Initiation of Clinical trial its overall monitoring and Archival
Authorities for Clinical Trial Application
Patient data listing and Case report forms
Bioavailability and Bioequivalence
Governing Regulatory Bodies across the globe and procedures
U.S Food & Drug Administration USDMF/NDA/ANDA/BLA
Canada Therapeutic Product Directorate DMF
Europe
Care Products
Product Filing
Responding Regulatory Deficiencies
Final Approval Procedure, Review of Dossier
Regulatory Audits
DCGI and WHO Submissions
Current Good Manufacturing Practice (cGMP)
Importance of GMP Compliance
QA/QC Documentation
Active Pharmaceutical ingredient and Finished Product
Validation
Annual product Quality Review
Complaints and Recall
Change Control
Advanced Diploma In Drug Regulatory Affairs at Elite Institute Pharma Skills Entry Requirements
Graduates and Masters from life science areas, Pharmacy, Biotechnology, Pharmacology, Microbiology and other professionals working with the hospitals, pathological Laboratories or Diagnostic Clinics
- Not mentioned
Other courses offered by Elite Institute Pharma Skills
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