Monday, April 21, 2014

Regulatory Affairs Courses with recent industry Study Materials

Indian Biosciences and Research Institute, NOIDA

Regulatory Affairs and Compliance
Course Rationale

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.

Course Modules

  1. Introduction to Regulatory Affairs 
  2. Introduction to Regulatory Affairs and Profession 
  3. International Licensing and Drug Regulatory Affairs 
  4. Regulatory Documentation for Biologics /Medical  Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.) 
  5. Global Regulatory Compliance Systems 
  6. Regulations for Clinical Trials, GMP, GLP and ICH Guidelines 
  7. Regulatory Strategy and Quality Assurance Systems 
  8. Future of Biopharmaceuticals

Course Durations

There are three different duration for the course

Certificate Program in Regulatory Compliances and Affair [3 Months]
Certificate Program in Regulations for Biologics and Pharmaceutical Product [6 Months]
Comprehensive Program in Regulatory Affairs for Pharmaceutics [12 Months]

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Posted By: Indian Biological Sciences and Research Institute, NOIDA

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