We have written this blog especially for freshers after consulting many job aspirant who has experienced interviews in PV recently (in 2019-20).
We have provided short answers to each questions however we have also provided few relevant links, where you can read in detail.
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” or
In other words Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines
Why is Pharmacovigilance important?
Pharmacovigilance is key to safety of drugs. PV analyses conducted in clinical trials of Phase I, Phase II and Phase III gives drug companies data on the drug’s safety profile.
Where necessary, these data may be used for further R&D or may be submitted to regulatory authorities to allow access to new markets.
Both PV practises in clinical research and those performed through medical professionals and consumers offer valuable insights into the pharmaceutical drug safety profile.
When identifying a new adverse reaction it is necessary to update the list of side effects on the label. Due to dangerous side effects, PV data can occasionally lead to the removal of a drug from the market (drug recall).
What are the minimum criteria required for a valid case?
- An identifiable reporter
- An identifiable patient
- A suspect product
- An adverse drug event
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.
What is an Adverse Drug Reaction (ADR)?
An adverse drug reaction is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.”
Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by drug at normal doses, during normal use.
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.
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.
What do you know about ICSR?
The full form of ICSR is Individual Case Study Report (ICSR). It is an adverse event report for an individual patient. ICSR is based on reports/information healthcare providers and patients in member countries of the WHO Programme.
Do you have any idea about VigiBase?
It is single largest drug safety data repository in the world. It is maintained by UMC (Uppsala Monitoring Centre)
What is Development Safety Update Report (DSUR)
“DSURs are new, globally harmonised safety documents (which became obligatory in the Member States of the European Union in September 2011) covering the safety overview of pharmaceutical products during their production process or clinical trials.
The new DSUR (defined in the ICH E2F Guideline) is heavily based on the PSUR format already used to update drug safety records during their marketing process. https://www.lifepronow.com/2020/09/19/development-safety-update-report-dsur/
When to submit DSUR?
Annually the DSUR is submitted in most countries. Companies with open INDs and NDAs (or ex-US equivalents such as CTCs / CTXs and MAs respectively) can also make their regulatory departments harmonise the birthdate for DSURs and PSURs in such a way that a single date for submission is available.
What is Periodic safety update reports (PSURs) in EU?
A Periodic Safety Update Report is a Pharmacovigilance document which is intended to provide an evaluation of a medicinal product’s risk-benefit balance at specified post-authorisation time points.
The objective of the PSUR to provide a systematic and important review of the product’s risk-benefit balance, taking into account new or evolving safety information in the sense of combined risk and benefit information.
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.
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 very serious
- Life threatening
- Hospitalization or prolongation of hospitalization.
- Congenital anomaly /Birth Defect
- Requiring intervention to prevent permanent damage or impairment
- Medically significant
What is the yellow card in pharmacovigilance?
The Yellow Card Scheme is the UK system for collecting information on the 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.
in 1964, the Scheme was founded after the thalidomide disaster, and was developed by Bill Inman.
What is informed consent?
Informed consent is process in which a health care provider educates the patient about the risks, benefits, and alternatives of the given procedure or intervention.
The informed consent form must be in patients native language or can be explained for easy understanding.
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)
What is Volume 9A?
Volume 9A brings together “The rules governing medicinal products in European Union”contains general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorisation Holders and Competent Authorities of the medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).
With the application of new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency.
What do the different part of Volume 9A deal with?
|Part I||deals with Guidelines for the Marketing Authorisation Holders;|
|Part II||deals with Guidelines for the Competent Authorities and the Agency;|
|Part III||provides the Guidelines for electronic exchange of pharmacovigilance in the EU|
|Part IV||provides Guidelines on the pharmacovigilance communication.|
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 in order to meet the FDA’s requirements for the 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 the FDA, provides for the review and ultimate approval of the generic drug product.
What do you mean by MedDRA?
Medical Dictionary for Regulatory Activities.
In the late 1990s, MedDRA, a rich and highly precise generic medical terminology, was established by the International Council for Harmonization of Technical Specifications for Pharmaceuticals for Human Use ( ICH) to promote the exchange of regulatory knowledge internationally for medical products used by humans.
MedDRA is available to all for use in the registration, documentation and safety monitoring of the medical products both before and after a product has been authorised for sale.
Products covered by the scope of the MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products.
Today, its increasing use by regulatory agencies, pharmaceutical firms, clinical research organisations and health care practitioners worldwide enables better global patient health safety.
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)
|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|
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
What is IND approval?
The Investigational New Drug ( IND) programme of the United States Food and Drug Administration is the means by which a pharmaceutical company obtains authorization to send an experimental drug across state lines (usually to clinical investigators) prior to the approval of a marketing application for the drug.
What is EudraVigilance?
The data-processing network and management system of the European Union, set up by the EMA to facilitate the electronic exchange, management and scientific assessment of individual case-safety reports on all medicinal products approved in the European Economic Area ( EEA).
EudraVigilance also incorporates data analysis facilities.
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 can be detected by asking patients directly or screening patient records.
Passive PV: Passive surveillance means that no active measures are taken to look for the adverse effects other than the encouragement of health professionals and others to report safety concerns.
What are the due dates for safety reporting?
Safety reporting due dates are 7 days for IND Reporting and 15 days for NDA Reporting
In order to prepare for any PV interview, You should have a basic knowledge/understanding of Pharmacovigilance, drug approval process and few terminologies which are common in clinical research.
As a fresher, you will get chance to work in ICSR mainly. So you should focus more on this. Aggregate report writing (PSUR, DSUR etc) is generally given to experienced individuals.
A good articles on ICSR: