M.Pharm Drug Regulatory Affairs

more_vert

Master of Pharmacy in Drug Regulatory Affairs

Duration

2 Years

Level

Post Graduation

Type

Degree

Eligibility

Graduation

M.Pharm Drug Regulatory Affairs or Master of Pharmacy in Drug Regulatory Affairs is a postgraduate Pharmacy program. The Drug Regulatory Affairs course contributes to a thorough understanding of the critical areas of Regulatory and Quality Compliance in the pharmaceutical sector.

Students are encouraged to broaden their understanding of regulatory and compliance challenges, as well as to pursue employment in these exciting times. The ever-changing laws and regulations are increasing the need for pharmaceutical regulatory affairs specialists that can assist corporations in bringing medical items to market effectively. The Master of Pharmacy program in Drug Regulatory Affairs is advantageous because it leads to a variety of employment.

M.Pharm Drug Regulatory Affairs Eligibility

  • Candidates must have passed a Bachelor’s degree or any other equivalent qualification from any recognized University 
  • The candidates should have secured a minimum of 45% aggregate marks in their Bachelor's.
  • Some of the very reputed universities and colleges conduct an entrance examination for admission.

M.Pharm Drug Regulatory Affairs Syllabus

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

M.Pharm Drug Regulatory Affairs Semester-I

Sr. No. 

Subjects of Study

1

Drug Approval & International Drug Regulations

2

Modern Analytical Techniques

3

National Regulatory Affairs

4

Pharmaceutical Regulatory Affairs

5

Practicals

  • Drug Approval & International Drug Regulations Lab
  • Modern Analytical Techniques Lab
  • National Regulatory Affairs Lab
  • Pharmaceutical Regulatory Affairs Lab

M.Pharm Drug Regulatory Affairs Semester-II

1

Clinical Trials & Healthcare Policies

2

International Regulatory Systems

3

Modern Analytical Techniques-II

4

Regulatory Aspects of Controlled Drug Delivery System

5

Practicals

  • Clinical Trials & Healthcare Policies Lab
  • International Regulatory Systems Lab
  • Modern Analytical Techniques Lab-II
  • Regulatory Aspects of Controlled Drug Delivery System Lab

M.Pharm Drug Regulatory Affairs Semester-III

1

Biostatics & Computer Applications

2

GLP, GMP, Quality Assurance & Validation

3

Practicals

  • Biostatics & Computer Applications Lab
  • Major Project Protocols & Synopsis
  • Major Project Protocol Presentation & Viva Voce
  • Term Paper (Evaluation)

M.Pharm Drug Regulatory Affairs Semester-IV

1

Major Project Experimental & Thesis

2

Major Project Presentation & Viva Voce

 

M.Pharm Drug Regulatory Affairs Colleges

M.Pharm Drug Regulatory Course Suitability

  • The Master of Pharmacy program in Drug Regulatory Affairs contributes to the availability of a pool of qualified experts in Pharmaceutical Regulatory Affairs.
  • The Drug Regulatory Affairs course is appropriate for providing quality contributions to Pharmaceutical Regulatory Affairs and developing documentation/research writing expertise in the Pharmaceutical Regulatory Affairs field.

How is the M.Pharm Drug Regulatory Course Beneficial?

  • The Master of Pharmacy program in Drug Regulatory Affairs prepares students to gather, analyze, and communicate the risks and benefits of healthcare products to regulatory authorities and the general public around the world.

M.Pharm Drug Regulatory Employment Areas

  • Colleges & Universities
  • Clinical Research Institutes
  • Overseas Careers
  • Pharma Industries

M.Pharm Drug Regulatory Job Types

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