The Diploma in Pharmaceutical Regulatory Sciences at Dow University of Health Sciences covers key aspects of regulatory frameworks for investigational, new, and generic drugs. It includes guidelines from agencies such as the US FDA, EMA, and Health Canada. The program also focuses on the importance of regulations in manufacturing pharmaceuticals, veterinary medicines, and medical devices to support effective and sustainable healthcare.
The curriculum runs for 6 months and is organised as streams: General Introduction; Regulations and Guidelines; Pre-Market Evaluation of Drugs; Current Good Manufacturing Practices; Quality Management System; Pharmaceutical Processes and Systems; Drug Development & Manufacturing Technology; Quality Control & Method Validation; Biologicals, Biosimilars and Clinical Studies; Supply Chain, Good Distribution Practices (GDP), and Cold Chain Management; and Post-marketing surveillance and pharmacovigilance.
Modules
- Stream 01 General Introduction
- Stream 02 Regulations and Guidelines
- Stream 03 Pre-Market Evaluation of Drugs
- Stream 04 Current Good Manufacturing Practices
- Stream 05 Quality Management System
- Stream 06 Pharmaceutical Processes and Systems
- Stream 07 Drug Development & Manufacturing Technology
- Stream 08 Quality Control & Method Validation
- Stream 09 Biologicals, Biosimilars and Clinical Studies
- Stream 10 Supply Chain, Good Distribution Practices (GDP), and Cold Chain Management
- Stream 11 Post-marketing surveillance and pharmacovigilance
