B.Pharma Important Question

BP-803T(F)/BP-804T(A)

Pharmaceutical Regulatory Science,  

VIII Sem, RGPV, B.Pharmacy

Unit I New Drug Discovery and development

Q.1 Describe in detail new drug approval process along with its documentation requirements as per USFDA. (RGPV Jun 2020)

Unit II Regulatory Approval Process

Q.1 Elaborate the following. (RGPV Jun 2020)

a) Timeline and types of IND.

b) Institutional review board.

Q.2 a brief overview of the regulatory authorities with reference to their organizational structure with special reference to USFDA and European union. (RGPV Jun 2020)

Unit III Registration of Indian drug product in overseas market

Q.1 What is the general procedure for export of pharmaceutical product? Discuss the requirement of Common Technical Document (CTD). (RGPV Jun 2020)

Q.2 Compare the documentation requirements of ANDA and NDA submissions. How innovator drug is different from generics drugs? (RGPV Jun 2020)

Q.3 What are various modules and requirements of electronic Common Technical Document (e CTD)? Compare it with ASEAN common technical documents (ACTD). (RGPV Jun 2020)

Unit IV Clinical trials

Q.1 Explain the role of pharmacovigilance in clinical trials monitoring. What are various GCP obligations of investigator and sponsor? (RGPV Jun 2020)

Unit V Regulatory Concepts

Q.1 Write short notes on any two of the following. (RGPV Jun 2020)

a) Drug Master File

b) Investigator brochure

c) Orange and Purple book

— Best of Luck for Exam —