Pharmaceutical Regulatory Science 8th Sem Imp Questions 2024

In this post pharmaceutical regulatory science 8th semester important questions are given for 2024. 

By using them you can get good marks in the examination. 

Therefore, consider all the questions given here as mandatory and be cautious in preparing answers to them. 

The pharmaceutical regulatory science important questions given here have been collected for the 8th sem exam only and some of these questions can be asked in this format. 

It is not that only these questions will be asked, these can also be twisted and put before you. 

To prepare informative answers to these, you should be clear on the pharmaceutical regulatory science topic. 

For this, you will have to read the lesson related to this topic in your textbook 2 to 3 times and understand its meaning. 

Only after this, it will be easy for you to write answers to the questions given here. 

First of all, write down all the questions of the regulatory science 8th semester question paper given here in your pharma notebook in sequence, after that write their answers. 

You should try to write all the answers in your own words. 

With this, you will be able to remember them easily and keep them in your mind for a long time. 

For the selection of questions of this set, previous question papers in addition to pharm regulatory science question bank have been made the basis. 

Those questions have been included here, which have been asked repeatedly in the past and are likely to be asked in the upcoming examination also. 

When you receive the question paper on this topic in the examination hall, make sure that there is no error of any kind in the question paper or that any page is missing. 

If such a thing happens, inform the invigilator about it. 

Start writing answers only after carefully reading the instructions on the first page of the pharmaceutical regulatory science question paper 8th sem in the examination hall. 

Try to express your views in as many words as are recommended in the instructions. 

From the set given here, you will get accurate information about the pattern of upcoming questions. 

Prepare excellent notes for yourself by solving the question paper on pharmaceutical regulatory science given below.

Pharmaceutical Regulatory Science Questions

8th Sem B Pharmacy Pharmaceutical Regulatory Science Important Questions

• Explain the functions of the US FDA.
• Define Investigational New Drug. Explain its types and categories.
• Explain the non–clinical studies in the process of New Drug Application.
• Write a note on the role and responsibilities of the lead investigator and Node principal investigator.
• Explain the GCP obligations of investigators sponsors and monitors.
• Explain in detail the regulatory bodies that govern the pharmaceutical sector in India.
• Explain the ethics, purpose, and importance of informed consent.
• Write a brief note on resources of IND applications. Explain the timelines involved in Investigational New Drug (IND).
• Explain the stages of drug discovery.
• Explain the changes to an approved ANDA and assess the manufacturing changes' effect.
• Write a short note on the following:- (a) Phase 2 clinical trial (b) Phase 3 clinical trial (c) WHO.
• Write a note on advanced technologies in drug discovery.
• Explain ICH (International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use).
• Explain in detail about Drug Price Control Order (DPCO) 1995.
• Explain the role and responsibilities of the sponsor and investigator in clinical trials.
• Write a note overview of the regulatory authorities of Japan.
• Discuss Pharmaceutical policy 2002.
• Write a note on the module and benefits of eCTD.
• Explain the Electronic Common Technical Document.
• Explain about institutional review board/Independent ethics committees (IECS).
• Write a short note on the Regulatory authorities of Canada.
• Describe the importance of the Hatch Waxman Act.
• Define CTA.
• Compare innovator and generics.
• Discuss in detail the contents of the orange book.
• Explain the Code of Federal Regulations and purple book.
• Define regulatory affairs.
• Write a short answer on the following:- (a) Functions of Ethics committee (b) Investigational Product (c) Three arm study. 
• What is a generic drug product?
• Explain the role of EMA and PDMA.
• What is a marketing authorization application?
• Explain in detail about functions of CDSCO.
• What is 180-day exclusivity?
• Write briefly about the guidance documents for NDAs.
• What do you mean by good clinical practice?
• Explain the procedure for the export of pharmaceutical products.
• Which ANDA process is applicable for 21 CFR Part 320? Explain the CFR, its history, and modern times of research tools in CFR.
• Write the name of the regulatory authorities of Australia and the USA.
• Write the full form of the following abbreviated terms:- (a) QMS (b) GPSP.
• Write a note on the organization of the ASEAN CTD format. Describe ASEAN Common Technical Document (ACTD) research.
• What is a branded drug?
• Explain and illustrate the pre-clinical studies.
• Write the task of post-marketing drug safety unity.
• Define bioinformatics.
• Explain about CTD and e CTD. Write about e-CTD management software. 
• Explain the overview of the regulatory authorities of India.
• What is a 505(b)(2) application?
• Elaborate on the Federal Register.
• What do you mean by draft Pharmaceutical Policy 2006?
• Write short notes on the following:- (a) Timelines involved in NDA (b) Drug Master File (c) Pharmacovigilance (d) GCP.
• What is a placebo?
• Explain the term 'Clinical Trials'. 
• Write a note on the procedure for obtaining a No Objection Certificate (NOC) for the export of unapproved, approved new drugs and banned drugs.

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