About the Diploma in Pharmaceutical Regulatory Sciences
This professional diploma program in Pharmaceutical Regulatory Sciences covers key as pects of regulatory frameworks for investigational, new, and generic drugs, including guide lines from agencies like the US FDA, EMA, and Health Canada. The program emphasizes the importance of regulations in manufacturing pharmaceuticals, veterinary medicines, and medical devices to ensure effective and sustainable healthcare. A basic understanding and experience in the pharmaceutical profession is required as a prerequisite. This program is essential for professionals to work effectively within their organizations.
Program Highlights
Duration
6 months
Curriculum
Program Structure
This program consists of a number of streams.
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
Eligibility Criteria
Following is the eligibility for admission in Diploma in Pharmaceutical Regulatory Sciences:
- GRADUATES WORKING IN THE PHARMA INDUSTRY
- CANDIDATES NOMINATED BY THE PHARMA/BIOTECH COMPANIES.
- THOSE INTERESTED IN REGULATORY AFFAIRS.
Admission Process
Every stage of our admissions process is aimed at identifying the aspects of your academic trajectory and personal ambitions
Your Career Starts Here!
Contact Us
Institute of Biological, Biochemical & Pharmaceutical Sciences (IBBPS)