We 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
5.
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
SUSAR - Suspected Unexpected Serious Adverse
Reaction
SAE - Serious Adverse Event
CIOMS - 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)
HIPAA - Health Insurance Portability and
Accountability Act
ESTRI - Electronic Standards for the Transfer
of Regulatory Information
IBD - International Birth Date
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