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, Health Canada, and CDSCO. 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 – INTRODUCTION OF REGULATORY AFFAIRS
STREAM 02 – PRE-MARKET EVALUATION OF DRUGS (CTD)
STREAM 03 – CURRENT GOOD MANUFACTURING PRACTICES
STREAM 04 – QUALITY MANAGEMENT SYSTEM
STREAM 05 – PHARMACEUTICAL PROCESSES & SYSTEMS
STREAM 06 – PRODUCTION (STERILE AND NON STERILE DRUG MANUFACTURING)
STREAM 07 – QUALITY CONTROL (CHEMICAL AND MICROBIOLOGY)
STREAM 08 – CLINICAL TRIALS (GCP, GLP)
STREAM 09 – SUPPLY CHAIN MANAGEMENT
STREAM 10 – POST-MARKET APPROVAL & RELEVANT GUIDELINES
Eligibility Criteria
Following is the eligibility for admission in Diploma in Pharmaceutical Regulatory Sciences:
- GRADUATES WORKING IN THEPHARMA 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
Contact Us
Institute of Biological, Biochemical & Pharmaceutical Sciences (IBBPS)