Comprehensive course in Drug regulatory Affairs

Overview

Course Modules: 

Certificate Course 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 Course in Food Regulatory Affairs [6 Months]

Paper-I: Introduction to the European Union and Food Regulatory Affairs
Paper-II: International Food Regulatory Affairs and Current issues
Paper-III: Food Regulatory Affairs in India (FSSAI, Approvals etc)
Paper-IV: Risk Analysis, HACCP, and Health

Comprehensive Program in Regulatory Affairs for Pharmaceutics [12 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
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

Eligibility:

Graduation and appearing Graduate

Course Duration:

1 Year

Course Fee:

14500

Contact:

Indian Biological Sciences and Research Institute

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