REGULATORY COMPLIANCES AND AFFAIRS
About Regulatory Affairs
Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including Pharmaceuticals, Veterinary Medicines, Medical Devices, Pesticides, Agrochemicals, Cosmetics and Complementary Medicines. Most companies, whether they are major multinational Pharmaceutical Corporations or Small, Innovative Biotechnology Companies, have specialist departments of Regulatory Affairs professionals. The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. With the aim of providing training IBRI has launched the course in Regulatory Affairs with the mission to train students and professionals who can help the industry to work under regulatory environment.
Comprehensive Program in Regulatory Affairs for Pharmaceutics [12 Months]
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
This course will help you to 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.
1-Exam fees are excluded from Course fees.
2- Course fees can be paid by Demand Draft (DD) / At Par Cheque / Cash in favor of "Indian Biosciences and Research Institute" payable at "NOIDA".