Pharmaceutical Regularory Affairs Certificate program

Module-1:

• Pharmaceutical industry and dosage forms
• Biotech industry and biological dosage forms
• Pharmacological classifications
• GMP in the Pharmaceutical industry and its applications for the API and dosage forms

Module-2:

• Regulations governing the Regulatory affairs
• Fundamentals of the Regulatory affairs in US, HC and EU
• Role of the ICH

Module-3

• Role of clinical trials and the regulations governing clinical trails

Module-4

• Regulatory of small molecules-Pharmaceuticals
• Regulatory of biologics
• Regulatory of cosmetics
• Role of clinical trials and the regulations governing clinical trails
• Regulatory of medical devices
• Post approval regulatory affairs
• Regulatory of natural health and OTC products
• Generic and new product rules
• Regulations governing the Regulatory affairs

Module-5

• Electronic submissions

For Course Schedule & Fees Please Call 416-821-4876.