Professional Certification Regulatory Affairs

The course 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.

RA Professional can get Employment as

1. Regulatory Affairs Associates
2. Regulatory Affairs Assistant
3. Regulatory Affairs Head/ Director
4. Medical Information Associates
5. Drug Inspector/Drug Controller
6. Drug Safety Specialist/ Regulatory Food Safety Scientist
7. Quality Operations/Quality Control/Quality Assurance
8. Regulatory Affairs Consultants

Type of companies hiring RA professionals
1. Pharmaceutical
2. Medical Devices
3. In Vitro Diagnostics
4. Biologics and Biotechnology
5. Veterinary Products
6. Cosmetics
7. Local FDA/ US FDA/UK MHRA/EDQM
8. Ministry of Health/DCGI
9. Clinical Research Organization/ Contract Research Organization
10. Pharmaceutical consultancy companies

Course Modules

Paper-I: Introduction to Regulatory Affairs
Paper-I: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

For further queries contact us @@@ 9999509892 or mail us at [email protected]
Our Website- www.ibri.org.in