Pharmaceuticals Regulatory Affairs

This program consists of 5 modules.

DURATION

TBA

PRACTICUM DURATION

N/A

ACCREDITATION

Equal Accreditation

FINANCIAL AID

Financial aid may be available to those who qualify

CAMPUS

• Markham
• North York

5 Modules

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

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