MSc Clinical Research and Regulatory Affairs

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Master of Science in Clinical Research and Regulatory Affairs

Duration

2 Years

Level

Post Graduation

Type

Degree

Eligibility

Graduation

MSc Clinical Research and Regulatory Affairs or Master of Science in Clinical Research and Regulatory Affairs is a Post-Graduate Medicine course. Clinical research is a field of medicine that investigates the safety and efficacy of drugs, equipment, diagnostic items, and treatment regimens designed for human use. These can be used for illness prevention, treatment, diagnosis, or symptom relief.

It will take at least two years to finish. This innovative program prepares graduate students to work as Clinical Research Associates (CRA), Medical Writers, Clinical Data Coordinators, Drug Development Associates, Business Development Managers, Clinical Project Managers, Clinical Research Managers, Regulatory Affairs Managers, and Biostatisticians in Contract Research Organizations (CROs), pharmaceutical companies, government agencies, or academia. The Master of Science program in Clinical Research and Regulatory Affairs is career-oriented and leads to several job opportunities upon graduation.

MSc Clinical Research and Regulatory Affairs Eligibility

  • Graduate from a recognized university in Health Sciences (MBBS / BDS / BHMS / BAMS / BUMS / BVSC / BSSM) or
    Graduate from a recognized university in Allied Health Sciences (BMLT / B.Sc MLT / BPT / BMIT / B.Sc MIT / BHIA / B.Sc HIA / BOT / B.Sc (Sp & Hg / BASLP / B.Sc Opt / B.Pharm / M.Pharm)  
    or
    Graduate from a recognized university in Life Sciences (Bio-Tech / Botany / Zoology / Microbiology / Chemistry / Nursing / Home Sciences/Food and Nutrition)
  • Some of the very reputed universities and institutes conduct entrance examinations for admission.

MSc Clinical Research and Regulatory Affairs Syllabus

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

Clinical Trial Document

Clinical Research Methodology

Clinical Research Design & Analysis

Clinical Research Data Management

Clinical Research Ethics & Regulatory Management

Clinical Research International Operation Management

Depth of the Pharmaceutical Industry

Evaluation in Clinical Research

Epidemiology in Clinical Research

English, Communication & Personality Development

Fundamental Clinical Research

Fundamental Principles of Pharmacy, Pharmacology, and Drug Action

Six Sigma Basic Certificate

Strategic Management and Organizational Changes in the Clinical Research Industry

Therapeutic Trial Area

Trade-related Aspects of Intellectual Property Rights

 

MSc Clinical Research and Regulatory Affairs Colleges

MSc Clinical Research and Regulatory Affairs Course Suitability

  • Candidates must also have good judgment and decision-making abilities, such as weighing the relative costs and advantages of many options before deciding on the best one.
  • The training is appropriate for students who have lab skills, are hard workers, can work long hours, and have managerial abilities.
  • They should be coordinating in nature, such as altering acts with respect to the actions of others.
  • Those with teaching talents who desire to become school teachers or college lecturers are ideal candidates.

How is the MSc Clinical Research and Regulatory Affairs Course Beneficial?

  • They can tackle complicated challenges after passing the Clinical Research and Regulatory Affairs course, such as recognizing complex problems and examining associated information to design and assess choices and implement solutions.
  • Candidates help in the preparation of scientific conference presentations and papers for technical journals, as well as attend scientific/professional meetings and training courses as needed.
  • The Clinical Research and Regulatory Affairs course also teaches financial resource management skills, such as establishing how the money will be spent to complete the task and accounting for these expenditures.

MSc Clinical Research and Regulatory Affairs Employment Areas

  • Defense Services
  • Government Hospitals
  • Health Ministry Administrative Jobs
  • Medical Writing
  • Medical Colleges & Universities
  • Private Clinics / Private Medical Labs

MSc Clinical Research and Regulatory Affairs Job Types

  • Clinical Enrolment Manager / Clinical Project Manager
  • Clinical Research Associate / Clinical Research Manager
  • Drug Development Associate
  • Lecturer / Professor
  • Medical Advisor / Medical Writer
  • Regulatory Affairs Manager