Regulatory Affairs

Indian Biosciences and Research Institute
Distance

Rs 10,500
VAT incl.
You can also call the Study Centre
91999... More
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Important information

  • Certificate
  • Distance learning
  • Noida /delhi/ncr
  • Duration:
    12 Months
Description

This course will help them understand the fundamental and concepts of regulation prevailing in various countries. It will enhance their knowledge and skills in the field of Regulatory affairs. The objectives of the course are: To create experts in the field of RA documentation and research. To encourage continuous learning and development in RA field. To update knowledge of existing RA professionals.
Suitable for: B Pharmacy/ M Pharmacy/ Science Graduate with working Experience

Important information
Venues

Where and when

Starts Location
On request
Noida /Delhi/NCR
C-50,First Floor, Sector-2,Noida, 201301, Uttar Pradesh, India
See map

Teachers and trainers (3)

Dr Abhinav Srivastava
Dr Abhinav Srivastava
Biotechnology

Mr. Ajay Viswakarma
Mr. Ajay Viswakarma
Bioinformatics

Mr. Mithilesh Mishra
Mr. Mithilesh Mishra
Information Technology

Course programme

Course-Paper-I: Introduction to Regulatory Affairs and Profession Course-Paper-II: International Licensing and Drug Regulatory Affairs Course-Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.) Course-Paper-IV: Global Regulatory Compliance Systems Course-Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH Guidelines Course-Paper-VI: Regulatory Strategy and Quality Assurance Systems Course-Paper-VII: Future of Biopharmaceuticals Course-Paper-VIII: Research Study

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