Exam Details
| Subject | Drugs Regulatory affairs | |
| Paper | ||
| Exam / Course | Post Graduate Diploma in Pharmaceutical sales Management (PGDPSM) | |
| Department | School of Vocational Education and Training (SOVET) | |
| Organization | indira gandhi national open university | |
| Position | ||
| Exam Date | December, 2016 | |
| City, State | new delhi, |
Question Paper
What do you mean by generic and OTC product? Describe in brief.
Write the different phases involved in evolution of Indian pharmaceutical Industries, indicate in tabular form.
Describe the different tasks performed by CDSCO. Enlist the major responsibilities of Dept. of Science and Technology (DST).
What does MAPE stands for? How are the retail prices of formulations calculated
What are the different phases in clinical evaluation of a drug in human beings? Describe phase III clinical trial in brief.
Define any two
Informed consent
Placebo
Ethics committee
What are the processes of approval of vaccines and other biologicals
Write the full forms and functions of following committee. (Any two)
GEAC
RDAC
IBSC
CBER
What are functions of DTAB and DCC
Define misbranded, adulterated and spurious drugs.
What do you understand by expiry date of a Drug?
Define the terms "Drug" and "cosmetics".
What are the details to be shown on the label of a medicine
Discuss the different factors affecting the potency of drug during storage.
8. Write short note on any two of the followings:
Medical Termination of Pregnancy Act.
Drugs and Magic Remedies Act.
Drug prices control order.
Paison Act.
Write the different phases involved in evolution of Indian pharmaceutical Industries, indicate in tabular form.
Describe the different tasks performed by CDSCO. Enlist the major responsibilities of Dept. of Science and Technology (DST).
What does MAPE stands for? How are the retail prices of formulations calculated
What are the different phases in clinical evaluation of a drug in human beings? Describe phase III clinical trial in brief.
Define any two
Informed consent
Placebo
Ethics committee
What are the processes of approval of vaccines and other biologicals
Write the full forms and functions of following committee. (Any two)
GEAC
RDAC
IBSC
CBER
What are functions of DTAB and DCC
Define misbranded, adulterated and spurious drugs.
What do you understand by expiry date of a Drug?
Define the terms "Drug" and "cosmetics".
What are the details to be shown on the label of a medicine
Discuss the different factors affecting the potency of drug during storage.
8. Write short note on any two of the followings:
Medical Termination of Pregnancy Act.
Drugs and Magic Remedies Act.
Drug prices control order.
Paison Act.
Other Question Papers
Departments
- Centre for Corporate Education, Training & Consultancy (CCETC)
- Centre for Corporate Education, Training & Consultancy (CCETC)
- National Centre for Disability Studies (NCDS)
- School of Agriculture (SOA)
- School of Computer and Information Sciences (SOCIS)
- School of Continuing Education (SOCE)
- School of Education (SOE)
- School of Engineering & Technology (SOET)
- School of Extension and Development Studies (SOEDS)
- School of Foreign Languages (SOFL)
- School of Gender Development Studies(SOGDS)
- School of Health Science (SOHS)
- School of Humanities (SOH)
- School of Interdisciplinary and Trans-Disciplinary Studies (SOITDS)
- School of Journalism and New Media Studies (SOJNMS)
- School of Law (SOL)
- School of Management Studies (SOMS)
- School of Performing Arts and Visual Arts (SOPVA)
- School of Performing Arts and Visual Arts(SOPVA)
- School of Sciences (SOS)
- School of Social Sciences (SOSS)
- School of Social Work (SOSW)
- School of Tourism & Hospitality Service Sectoral SOMS (SOTHSM)
- School of Tourism &Hospitality Service Sectoral SOMS (SOTHSSM)
- School of Translation Studies and Training (SOTST)
- School of Vocational Education and Training (SOVET)
- Staff Training & Research in Distance Education (STRIDE)
Subjects
- Drugs Regulatory affairs
- Introduction to Anatomy, Physiology and Pharmaceutical Chemistry
- Introduction To Management
- Pharmaceutics
- Pharmacology and Toxicology
- Sales management