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, 2015 | |
| City, State | new delhi, |
Question Paper
Give the full forms of any five:
UNISEF
DPCO
TRIPS
GATT
IPA
CRAMS
OTC
What are the major sectors of Indian pharmaceutical industry?
What do you understand by the Regulatory authorities?
Discuss the different functions of National Pharmaceutical Pricing Authority (NPPA).
What is preclinical evaluation of drugs?
What is acute toxicity study?
What is placebo?
4. Discuss in brief:
What is the process of approval of vaccines?
What are the composition of Institutional Bio-Safety Committee (IBSC)
5. Explain anyone in detail:
What is the mandatory information that is supposed to be provided when filing the Investigational New Drug Application
Discuss the Requirement of permission to import and manufacture fixed dose combinations.
Discuss the constitution of Pharmacy Council of India.
Discuss the Pharmacy Act.
What is Drug Technical Advisory Board Give its Constitution.
What are the powers of Drug Inspectors as per Drugs and Cosmetics Act
8. Explain any two
What are drugs and magic Remedies Act?
What are the Poison Act, 1919
What is medicinal and toilet preparation (Excise duty) act?
UNISEF
DPCO
TRIPS
GATT
IPA
CRAMS
OTC
What are the major sectors of Indian pharmaceutical industry?
What do you understand by the Regulatory authorities?
Discuss the different functions of National Pharmaceutical Pricing Authority (NPPA).
What is preclinical evaluation of drugs?
What is acute toxicity study?
What is placebo?
4. Discuss in brief:
What is the process of approval of vaccines?
What are the composition of Institutional Bio-Safety Committee (IBSC)
5. Explain anyone in detail:
What is the mandatory information that is supposed to be provided when filing the Investigational New Drug Application
Discuss the Requirement of permission to import and manufacture fixed dose combinations.
Discuss the constitution of Pharmacy Council of India.
Discuss the Pharmacy Act.
What is Drug Technical Advisory Board Give its Constitution.
What are the powers of Drug Inspectors as per Drugs and Cosmetics Act
8. Explain any two
What are drugs and magic Remedies Act?
What are the Poison Act, 1919
What is medicinal and toilet preparation (Excise duty) 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