Interview Questions.

Question 1. What Is Regulatory Affairs?

Answer :

Regulatory Affairs in a Pharmaceutical enterprise, is a profession which acts as the interface among the pharmaceutical industry and Drug Regulatory government across the world. It is specially involved within the registration of the drug products in respective nations previous to their advertising.

Question 2. What Are The Goals Of Regulatory Affairs Professionals?

Answer :

Protection of human fitness
Ensuring protection, efficacy and high-quality of medicine
Ensuring appropriateness and accuracy of product facts
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Question 3. What Are The Roles Of Regulatory Affairs Professionals?

Answer :

Act as a liaison with regulatory corporations.
Preparation of organized and scientifically valid NDA, ANDA,INDA ,MAA,DMF submissions.
Ensure adherence and compliance with all the relevant cGMP, ICH, GCP, GLP pointers, guidelines and laws.
Providing expertise and regulatory intelligence in translating regulatory necessities into practical manageable plans.
Advising the organizations on regulatory components and climate that might affect their proposed activities.
Apart from the above foremost roles, there are various other roles which Regulatory Affairs specialists play.
Question four. What Is An Investigational New Drug (ind) Application?

Answer :

It is an utility that is filed with FDA to get approval for legally testing an experimental drug on human topics inside the USA.

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Question five. What Is A New Drug Application?

Answer :

The NDA is the automobile through which drug sponsors officially endorse that the FDA approve a brand new pharmaceutical on the market and advertising and marketing in the U.S.  The facts collected throughout the animal studies and human scientific trials of an Investigational new drug end up part of the NDA

In simple phrases, “It is an utility that is filed with FDA to market a brand new Pharmaceutical for sale in USA”

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Question 6. What Is An Abbreviated New Drug Application (anda)?

Answer :

It is an software filed with FDA, for a U.S. Prevalent drug acclaim for an present licensed medication or accredited drug.

In easy phrases, “It is an application for the approval of Generic Drugs “

Question 7. What Is A Generic Drug Product?

Answer :

A typical drug product is the one this is corresponding to an innovator drug product in dosage form, energy, direction of management, best, overall performance characteristics and supposed use. 

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Question 8. What Is A Dmf?

Answer :

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential precise information approximately centers, approaches, or articles used inside the manufacturing, processing, packaging, and storing of one or greater human capsules.

Important statistics concerning DMFs :

It is submitted to FDA to offer exclusive statistics
Its submission isn't required by regulation or guidelines
It is neither approved nor disapproved
It is filed with FDA to assist NDA, IND, ANDA another DMF or amendments and dietary supplements to any of those
It is furnished for in the 21 CFR (Code of Federal Regulations) 314. 420
It isn't always required while applicant references its very own records
Question 9. What Are The Types Of Dmf’s?

Answer :

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer general by FDA)
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information (FDA discourages its use)
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Question 10. What Is A 505 (b)(2) Application ?

Answer :

505 (b)(2) application is a form of NDA for which one or extra investigations relied on via applicant for approval were no longer carried out with the aid of/for applicant and for which applicant has no longer received a proper of reference.

Question 11. What Kind Of Application Can Be Submitted As A 505(b)(2) Application?

Answer :

New chemical entity (NCE)/new molecular entity (NME)
Changes to previously approved tablets
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Question 12. What Are The Examples Of Changes To Approved Drug Products For Which 505(b)(2) Application Should Be Submitted ?

Answer :

Change in dosage form.
Change in strength.
Change in path of administration.
Substitution of an active aspect in a formulation product.
Change in components.
Change in dosing regimen.
Change in active ingredient.
New mixture Product.
New indication.
Change from prescription indication to OTC indication.
Naturally derived or recombinant lively component.
Bioinequivalence.
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Question 13. What Are The Chemical Classification Codes For Nda?

Answer :

New molecular entity (NME)
New ester, new salt, or different noncovalent spinoff
New formulation
New combination
New manufacturer
New indication
Drug already marketed, but without an accepted NDA
OTC (over-the-counter) switch
Question 14. What Are The Differences Between Nda And 505 (b)(2) Application?

Answer :

New Drug Application (NDA) :

All investigations depended on by using applicant for approval have been carried out via/for applicant and for which applicant has proper of reference.
Generally, filed for newly invented pharmaceuticals.
505 (b)(2) Application :

One or greater research depended on by using applicant for approval were not conducted via/for applicant and for which applicant has not received a proper of reference.
Generally, filed for brand spanking new dosage shape, new direction of management, new indication and many others for all already accredited pharmaceutical.
 

Question 15. What Is A Marketing Authorization Application?

Answer :

It is an software filed with the applicable authority in the Europe (usually, the United Kingdom's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicinal drug.

As in line with UK’s MHRA-

Applications for new lively substances are defined as 'complete packages'.
Applications for drug treatments containing existing lively materials are defined as 'abbreviated’ or ‘abridged packages’.
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Question sixteen. What Is An Asmf?

Answer :

Active substance grasp record is a submission that's made to EMA, MHRA or every other Drug Regulatory Authority in Europe to provide confidential intellectual assets or 'understanding' of the producer of the lively substance.

In simple phrases, “It is a submission made to European Drug regulatory businesses at the private records of Active Substance or Active pharmaceutical Ingredient (API)”.

Question 17. What Are The Types Of Active Substances For Which Asmfs Are Submitted?

Answer :

New energetic materials
Existing lively materials now not included within the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State
Pharmacopeial active substances covered inside the Ph. Eur. Or in the pharmacopoeia of an EU Member State
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Question 18. What Is The Difference Between Dmf And Asmf (with Respect To Submission)?

Answer :

ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part)
There isn’t any differentiation of DMF’s into elements
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Question 19. What Is Ich?

Answer :

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a task that brings together the regulatory authorities of Europe, Japan and the USA and specialists from the pharmaceutical industry inside the three areas to discuss scientific and technical components of pharmaceutical product registration.

Question 20. What Is Ctd?

Answer :

The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the USA.Quality, Safety and Efficacy records is assembled in a not unusual layout via CTD .The CTD is maintained with the aid of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

CTD format for submission of drug registration programs/dossiers is widely standard by way of regulatory authorities of different international locations too like Canada, Australia and so on. 

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Question 21. What Are The Ich Guidelines To Be Referred For Preparation Of Registration Dossiers/programs Of Medicines (with Respect To Format And Contents In Each Module)?

Answer :

M4   Guideline
M4Q Guideline
M4S Guideline
M4E Guideline
Question 22. What Are The Modules In Ctd?

Answer :

The Common Technical Document is split into 5 modules:

Module 1 : Administrative statistics and prescribing records
Module 2 :Common Technical Document summaries (Overview and summary of modules 3 to five)
Module three : Quality 
Module four : Nonclinical Study Reports (toxicology studies)
Module 5 : Clinical Study Reports (medical studies)
Question 23. What Is Orange Book?

Answer :

It is the commonly used name for the e book “Approved Drug Products with Therapeutic Equivalence Evaluations”, that's published by means of USFDA.

It contains the list of drug products, accredited on the idea of safety and effectiveness by means of the Food and Drug Administration (FDA) below the Federal Food, Drug, and Cosmetic Act.

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Question 24. What Is Hatch-waxman Act?

Answer :

It is the popular call for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark rules which mounted the contemporary device of commonplace drugs in USA. Hatch-Waxman change of the federal food, drug and cosmetics act installed the system through which, would be entrepreneurs of accepted capsules can file Abbreviated New Drug Application (ANDA) to searching for FDA approval of everyday tablets. Paragraph IV of the act, allows one hundred eighty day exclusivity to agencies which might be the "first-to-record" an ANDA towards holders of patents for branded counterparts.

In simple phrases “Hatch-Waxman act is the modification to Federal, Food, Drug and Cosmetics act which hooked up the present day device of approval of generics ”

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Question 25. What Are The Patent Certifications Under Hatch-waxman Act?

Answer :

As in keeping with the Hatch and Waxman act, customary drug and 505 (b) (2) applicants should encompass certifications of their programs for each patent indexed within the “Orange Book” for the innovator drug. This certification need to kingdom one of the following:

that the desired patent information referring to such patent has no longer been filed (Para I certification);
that such patent has expired (Para II certification);
that the patent will expire on a particular date (Para III certification); or
that such patent is invalid or will no longer be infringed by the drug, for which approval is being sought(Para IV certification).
A certification below paragraph I or II permits the ANDA to be accepted right away, if it's miles otherwise eligible. A certification under paragraph III suggests that the ANDA can be accredited whilst the patent expires.

Question 26. What Is Meant By one hundred eighty Day Exclusivity?

Answer :

The Hatch-Waxman Amendments offer an incentive of 180 days of market exclusivity to the “first” common applicant who demanding situations a listed patent by filing a paragraph IV certification and thereby runs the chance of having to shield a patent infringement match.

A hundred and eighty Day Exclusivity might be granted to multiple applicant. The latest instance is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing general model of  Lipitor ( Atorvastatin calcium).

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Question 27. What Are The Procedures For Approval Of Drug In Eu?

Answer :

Centralised Procedure (CP)
Decentralised Procedure (DCP)
Mutual Recognition Procedure (MRP)
National Procedure (NP)
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Question 28. What Is The Full Form Of Abbreviation, Cep?

Answer :

Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs

It is likewise informally called Certificate of Suitability (COS)

Question 29. What Is A Cep?

Answer :

It is the certificates which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), while the producer of a substance offers proof that the first-rate of the substance is definitely managed with the aid of the relevant monographs of the European Pharmacopoeia.

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Question 30. What Are The Well Known Drug Regulatory Agencies Across The World?

Answer :

United States of America : United States Food and Drug Administration (USFDA)
United Kingdom : Medicines and Healthcare products Regulatory Agency (MHRA)
European Union : European Medicines Agency (EMA)
European Union : European Directorate for the Quality of Medicines (EDQM)
Australia : Therapeutic Goods Administration (TGA)
Canada : Therapeutic Products Directorate  (TPD) in Health Product and meals branch (HPFB) of Health Canada (HC)
Japan : Pharmaceutical and Medical Devices Agency (PMDA)
France :  French Agency for the Safety of Health Products
Germany : Federal Institute for Drugs and Medical Devices
Brazil : The National Health Surveillance Agency
India : Drugs Controller General of India (DCGI) who heads Central Drugs Standard Control Organisation (CDSCO)
Switzerland : Swiss Agency for Therapeutic Products (SWISSMEDIC)
Singapore : Health Sciences Authority (HSA)
New Zealand : New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)