Advance Diploma in Clinical Research and Pharma Regulatory Affairs

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Duration

3 to 6 Months

Level

Post Graduation

Type

Diploma

Eligibility

Graduation

Advance Diploma in Clinical Research and Pharma Regulatory Affairs is a postgraduate Medicine course. Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. This novel program provides necessary training for graduate students to develop diverse careers as Clinical Research Associates (CRA), Medical Writers, Clinical Data Coordinators, Drug Development Associates, Business Development Managers, Clinical Project Manager, Clinical Research Manager, Regulatory Affairs Manager and Biostatisticians in Contract Research Organizations (CROs), pharmaceutical companies, government agencies or academia. The course is career orienting in nature that provides many jobs after its successful completion. The duration of the course is three months on a minimum basis and six months on a maximum basis.

Advance Diploma in Clinical Research and Pharma Regulatory Affairs Eligibility         

  • Graduate from recognized university in Health Sciences (M.B.B.S./B.D.S./B.H.M.S./B.A.M.S./B.U.M.S./B.V.S.C./ B.S.S.M.) 
  • or
    Graduate from recognized university in Allied Health Sciences-(B.M.L.T./B.Sc. MLT/B.P.T./BMIT/B.Sc. MIT/BHIA/B.Sc. HIA/BOT/B.Sc.(Sp & Hg/BASLP/B.Sc. Opt B.Pharm./M.Pharm.)  
    or
    Graduate form 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 examination for admission.

Advance Diploma in Clinical Research and Pharma Regulatory Affairs Syllabus

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

Sem. I

Sr. No.

Subjects of Study

1         

Introduction to Clinical Research

2         

Guidelines, Regulation & Ethics in Clinical Research

3         

Clinical Trial Management & Quality Management

4         

Pharma Regulatory Affairs

 

Specialization

1         

Clinical Data Management(link)

2         

Pharmacoviglance (link)

3         

Medical Writing(link)

 

Advance Diploma in Clinical Research and Pharma Regulatory Affairs Colleges

Advance Diploma in Clinical Research and Pharma Regulatory Affairs Course Suitability

  • Candidates also possess judgment and decision-making skills like considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • The course is suitable for those who have lab techniques, hard worker, can work for long hours and have managerial skills. 
  • They should have coordinating nature such as adjusting actions in relation to others' actions.
  • Those who have teaching skills and want to become teacher at school level and lecturer at college are good suit for it. 

How is Advance Diploma in Clinical Research and Pharma Regulatory Affairs Course Beneficial?

  • After passing the course they can solve complex problem such as identifying complex problems and reviewing related information to develop and evaluate options and implement solutions. 
  • Candidates assist in preparation of presentations and manuscripts of scientific meetings and technical journals and attend scientific/professional meetings and training courses as appropriate. 
  • The course also provides skills regarding management of financial resources such as determining how money will be spent to get the work done, and accounting for these expenditures.

Advance Diploma in Clinical Research and Pharma Regulatory Affairs Employment Areas

  • Colleges & Universities
  • Community Health Centres
  • Government Hospitals
  • Medical Writing
  • Nursing Homes
  • Pharma Companies
  • Pharmacist Shops
  • Private Clinics

Advance Diploma in Clinical Research and Pharma Regulatory Affairs Job Types

  • Clinical Data Coordinator
  • Clinical Enrolment Manager
  • Clinical Project Manager
  • Clinical Research Associate
  • Clinical Research Coordinator
  • Clinical Research Manager
  • Drug Development Associate
  • Medical Advisor
  • Medical Writer
  • Regulatory Affairs Manager