Clin Infotech

In every interview that you might attend, you always wish to know the questions beforehand. However, you should keep in mind that the panel sitting in front of you is experienced and can go a step higher if you can steer clear from their simple volleys. No list of questions or guide is perfect but they all are for the preparation of better good. We bring forth to you a list of few academic questions that might make the tortuous path a little easier.

  1. What is Pharmacovigilance?

Pharmacovigilance has been defined by the World Health Organisation (WHO) as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem”

2. What are the minimum criteria required for a valid case?

  1. An identifiable reporter
  2. An identifiable patient
  3. A suspect product
  4. An adverse drug event

3. What is an Adverse Drug Event (ADE)?

The ICH E2A guideline describes Adverse Events as any “untoward medical occurrence” which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to that person.  

4. What is an Adverse Drug Reaction (ADR)?

ICH E2A characterizes Adverse Reactions according to the stage of the medicinal product’s life cycle. If the product has not yet been marketed, Adverse Reactions are any “noxious and unintended responses” to the product at any dose. The effect of this classification is to reasonably establish that a relationship between the product and the reaction “cannot be ruled out”. Once the product has been placed in the market, “Adverse Reactions” encompass responses which are again “noxious and unintended” but occur at the established routine dosages which have been defined for use in humans to prevent, diagnose, or treat disease or modify “physiological function”.

5. What is the difference between an ADE and ADR?

Adverse drug event and adverse drug reaction both are adverse occurrence but if one finds the causality for adverse occurrence its adverse drug reaction and if one fails to find causality for adverse occurrence then it is referred to as adverse drug event.

6. What do you mean by causality?

Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event.

7. When do you consider an event to be serious?

If an event is associated with any one of the following, it is considered to be serious

  1. Death
  2. Life threatening
  3. Hospitalization or prolongation of hospitalization.
  4. Congenital anomaly /Birth Defect
  5. Disability
  6. Requiring intervention to prevent permanent damage or impairment
  7. Medically significant

8. What is the yellow card in pharmacovigilance?

The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman.

9.What is informed consent?

Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information.

10.Name the regulatory bodies in USA, UK, Japan and India?

USA: United States Food and drug administration (USFDA).

UK: European Medicines Agency (EMEA).

Japan: Ministry of Health, Labour and Welfare (MHLW).

India: Central Drugs Standard Control Organization (CDSCO)

11.What is Volume 9A?

Volume 9A brings together “The rules governing medicinal products in the European Union”contains  general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorisation Holders and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH). With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency.

12.What do the different part of Volume 9A deal with?

Part I deals with Guidelines for Marketing Authorisation Holders;

Part II deals with Guidelines for Competent Authorities and the Agency;

Part III provides the Guidelines for the electronic exchange of pharmacovigilance in the EU

Part IV provides Guidelines on pharmacovigilance communication.

13. Difference between NDA and ANDA?

NDA means New Drug Application. When the sponsor of the new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application.

ANDA means Abbreviated New Drug Application. It contains data that, when submitted to FDA, provides for the review and ultimate approval of a generic drug product.

14.What are the phases of clinical trials?

Phase I studies assess the safety of a drug or device. 

Phase II studies test the efficacy of a drug or device.

Phase III studies involve randomized and blind testing in several hundred to several thousand patients. 

Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale.

15. What do you mean by MedDRA?

Medical Dictionary for Regulatory Activities.

16.Explain the hierarchy in MedDRA.

  • System Organ Class (SOC)
  • High Level Group Term (HLGT)
  • High Level Term (HLT)
  • Preferred Term (PT)
  • Lower Level Term (LLT)

17. Abbreviations


Suspected Unexpected Serious Adverse Reaction

  • SAE

Serious Adverse Event


Council for International Organizations of Medical Sciences

  • ADE

Adverse Drug Event

  • SSAR

Suspected Serious Adverse Reaction

  • ADR

Adverse Drug Reaction

  • ICSR

Individual Case Safety Report

  • PSUR

Periodic Safety Update Report

  • ICH

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)


Health Insurance Portability and Accountability Act


Electronic Standards for the Transfer of Regulatory Information

  • IBD

International Birth Date

18. What do you know about E2a, E2b and E2c guidelines?

  • E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • E2B (R2) Maintenance of the Clinical Safety Data Management including Data Elements for          Transmission of Individual Case Safety Reports
  • E2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
  • E2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
  • E2C (R2) Periodic Benefit-Risk Evaluation Report

19.What is IND approval?

The United States Food and Drug Administration’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

20.What is EudraVigilance?

The European Union data-processing network and management system, established by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports related to all medicinal products authorised in the European Economic Area (EEA). EudraVigilance also incorporates data analysis facilities.

21. What are the types of Pharmacovigilance (PV)?

  Two types. 1. Active PV and 2.Passive PV

Active PV: Active (or proactive) safety surveillance means that active measures are taken to detect adverse events. This is managed by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records.

Passive PV: Passive surveillance means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns.

22.What are the due dates for safety reporting?

Safety reporting due dates are 7 days for IND Reporting and 15 days for NDA Reporting

23.What is inverted Black triangle in Pharmacovigilance?

A black triangle appearing after the trade name of a British medicine indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration.The black triangle also highlights the need for surveillance of any adverse drug reaction (ADRs) that might arise from the use of a new medication.

24.What is Pharmacovigilance Programme of India (PvPI)?

The Central Drugs Standard Control Organisation (CDSCO), New Delhi has initiated a nation-wide pharmacovigilance programme under the aegis of Ministry of Health & Family Welfare, Government of India. The programme is coordinated by The Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. The National Coordinating Centre (NCC) is operating under the supervision of Steering Committee to recommend procedures and guidelines for regulatory interventions in India.

25.What is a signal?

A ‘signal’ consists of reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.