Post Graduate Diploma in Drug Regulatory Affairs

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Duration

1 Years

Level

Diploma After 10+2

Type

Diploma

Eligibility

10+2 (PCB)

Post Graduate Diploma in Drug Regulatory Affairs is a Diploma level Pharmacy programme. The course helps to provide a comprehensive education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. Students are encouraged to enhance their knowledge of regulatory and compliance issues and to explore careers in these exciting times. The ever-changing laws and regulations are driving demand for pharmaceutical regulatory affairs professionals, who can help companies effectively bring medical products to market. The course is beneficial as it offers many careers them after passing it successfully.

Post Graduate Diploma in Drug Regulatory Affairs Eligibility

  • Candidates should be a Graduate in Science Stream or its equivalent in any other from a recognized university board.
  • Some of the very reputed universities and colleges conduct an entrance examination for admission.

Post Graduate Diploma in Drug Regulatory Affairs Syllabus

Syllabus of Drug Regulatory Affairs as prescribed by various Universities and Colleges.

Sem. I

Sr. No.

Subjects of Study

1         

Fundamentals of Regulatory Affairs 

2         

International Regulatory Requirements

3         

Pharmaceutical cGMP & Validation

4         

Modern Analytical Techniques

5         

Pharmaceutical Regulatory Affairs Lab

6         

Modern Analytical Techniques Lab

7         

Seminar/Journal Club

8         

Project-I

Sem. II

1         

Clinical Trial Regulations

2         

Preclinical Studies and Toxicity & Toxic kinetics

3         

Intellectual Property Rights& Documentation

4         

Clinical Trial Regulations Lab

5         

Seminar/Journal Club

6         

Industrial Training

7         

Project-II

 

Post Graduate Diploma in Drug Regulatory Affairs College

Post Graduate Diploma in Drug Regulatory Affairs Course Suitability

  • Post Graduate Diploma in Drug Regulatory Affairs is suitable to provide quality inputs in pharmaceutical regulatory affairs and to develop documentation/research writing expertise in the field of pharmaceutical regulatory affairs. 
  • The course helps to make available a pool of competent professionals in Pharmaceutical Regulatory Affairs.

How is the Post Graduate Diploma in Drug Regulatory Affairs Course Beneficial?

  • The Course is beneficial to deal with the knowledge and skills of collecting, analyzing and communicating the risks and benefits of healthcare products to regulatory agencies and public all over the world.

Post Graduate Diploma in Drug Regulatory Affairs Employment Areas

  • Colleges & Universities
  • Content Writing (medical) 
  • Medicine Manufacturing Companies
  • Nursing Homes
  • Pharmacist Shops
  • Self-run-Clinics

Post Graduate Diploma in Drug Regulatory Affairs Job Types

  • Drug Inspector/Drug Controller
  • Drug Safety Specialist
  • Medical Information Associate
  • Quality Control/Quality Assurance
  • Regulatory Administrator
  • Regulatory Affairs Associate
  • Regulatory Affairs Consultant
  • Regulatory Affairs Head
  • Regulatory Compliance Manager
  • Regulatory Food Safety Scientist