GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course
Pharmacovigilance Tasks in General and interview Questions
Q: What are Pharmacovigilance tasks in General?
A: The following are the tasks which need to be handled in any Pharmacovigilance company.
- ICSRs (Individual Case Safety Reports)
- PSURs (Periodic Safety Update Report). This task is termed as PBRER (Periodic Benefit Risk Evaluation Report) in EUROPE and PADER (Periodic Adverse Drug Experience Report) in USA
- Signal Management
- RMP (Risk Management Plan). This task is termed as RMP in EUROPE and REMS (Risk Evaluation and Mitigation Strategies) in USA
- Labelling Change Updates
- Line Listings and Summary of Product Characteristics
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Q: What are Sources of ICSRs?
A: ICSRs may arise from unsolicited sources such as
- Consumer reports
- Health care professional’s reports
- Regulatory Authority reports
- Literature reports
- Reports from Non-medical sources
- Reports from Internet or digital media
ICSRs may arise from Solicited sources such as
- Studies after post marketing stage of product
- Surveys from Marketing company
- patient support and disease management programmes
- non-interventional studies,
- registries etc
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Steps involved in ICSR handling?
A: The following are sequence of actions
- Identification of case validity: Validity is based on 4 Minimum criteria (Identifiable patient, Suspect drug, Adverse Reaction, Reporter). If case does not meet the criteria, no need to process that case. That case is invalid case.
- Duplicate check: Check whether the valid case is already there or not by checking the duplicates. If found any duplicate, then the current case need to checked for any updated information than the old case. If found any updated information, then this case need to be treated as follow up for that duplicate case.
- If it is fresh case without duplicates, then register the case in Database as new case. This registration is called as Bookin or Triage. This step is Initial data entry (4 minimum criteria).
- Databases used in general are ArisG, ARGUS, Oracle, ClinTrace, Clinovo.
- Once case is registered in Database, then Data Entry step starts here. This is complete data entry. Whatever the information in the source document need to be entered into the database.
- Any database have sections such as Patient, Reporter, Event, Product, Narrative.
- Narrative writing: For every case, Narrative summary need to be written in Narrative section of Data base. It means framing the case details in summarized manner which gives a clear picture of entire case.
- MedDRA coding: MedDRA is a dictionary which is used universally in Pharmacovigilance to give codes to the Events, past medical history, Indications of case. Data bases have inbuilt MedDRA which helps the data entry person to auto populate the codes.
- QC (Quality Check) Step: This is done actually to verify if any data is missing by the data entry person while doing. This step will be done by Experienced person
- Medical Review (MR): This step need to be done by medically Qualified persons (doctors). Medical assessment means, assessment of causality (whether event is related to product or not) in the case by checking the Company product information leaf let. Finally, to make a judgement that, this event is medically confirmed and need to be monitored.
- Data bases have privileges as DE, QC, MR pages.
- Submission: It means, reporting of this case to Regulatory Authority from Database. Case will be pushed from MR step to next flow i.e. Submission page. At this step, case will be submitted and acknowledge form will be generated as a receipt.
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Q: ArisG Full form in Pharmacovigilance?
A: Adverse Reaction Information System Global
Q: What is ARGUS Full form in Pharmacovigilane?
A: Adverse Reaction Global Update System
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Ques: What to be reported as ICSRs as per FDA guidelines?
A: ICSRs need to be submitted within 15 calendar days. Those follows as below
- Serious and unexpected (Unlisted) adverse experiences from all sources (domestic and foreign) need to be reported as ICSRs. Possible sources includes scientific literature, post marketing studies, or commercial marketing experience.
- Reports of serious, unexpected adverse experiences described in the scientific literature should be submitted for products that have the same active moiety as a product marketed in The United States. This is true even if the excipient, dosage forms, strengths, routes of Administration, and indications vary.
- Reports of foreign serious, unexpected adverse experiences should be submitted for Products that have the same active moiety as a product marketed in the United States. This is true even if the excipient, dosage forms, strengths, routes of administration, and indications vary.
- Cases with increased frequency of serious and labelled events (foreign and domestic)
- Study reports (Foreign and domestic) must only be submitted if there is a reasonable possibility that the drug caused the adverse experience
- An adverse experience associated with the use of a product for an unapproved indication should be reported to the FDA as is required for any other spontaneously reported adverse experience occurring in the United States
- Applicants that receive individual case safety reports from FDA are not required to resubmit them to the Agency. However, follow-up information to these initial reports must be submitted to the FDA.
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Q: What is timeline for Serious case submission in USA as per FDA?
A: 15 Calendar days.
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Q: is it ok to submit the Non serious cases as ICSRs in USA as per FDA?
A: No need to submit the Non-serious cases as ICSRs. These must be submitted to FDA in and as PADERs.
Q: What is timeline for Serious case submission in Europe as per EMEA?
A: 15 Calendar days.
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Q: What is timeline for Non-Serious case submission in Europe as per EMEA?
A: 90 Calendar days.
Q: What is timeline for Serious case submission in Australia as per TGA?
A: 15 Calendar days.
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Q: What is timeline for Non-Serious case submission in Australia as per TGA?
A: These are not required to be routinely reported. However, they must be presented as a cumulative table in a Periodic Safety Update Report (PSUR) as per PSUR reporting requirements.
Q: What is timeline for Serious case submission in New Zealand as per MedSafe?
A: 15 Calendar days
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Q: What is timeline for Non-Serious case submission in New Zealand as per MedSafe?
Ans: Sponsors are not required to report non-serious adverse reactions. However, sponsors should be able to provide these reports on request from Medsafe and include these in Periodic Benefit Review Evaluation Reports (PBRERs).
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Signal Management Process in General
Q: What is Signal?
A: Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be Signal.
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Q: What is signal management process?
A: Signal Management process is a set of activities performed to determine the signals based on an examination of information from various data sources.
The signal management process includes the activities as signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action.
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Q: What is signal detection?
A: The process of looking for and/or identifying signals using data from any source is called as signal detection.
Q: What are the sources of signals?
A: Signal sources can be from
- spontaneous reporting,
- active monitoring systems
- interventional studies (clinical trials)
- non-interventional studies (pharmacoepidemiology studies)
- non-clinical studies (e.g. animal toxicology studies)
- systematic reviews (i.e. thorough review of the published literature)
- meta-analyses (i.e. mathematical pooling of all the clinical trial data)
- other relevant sources
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Q: What is Signal validation?
A: The process of evaluating the data supporting the detected signal in order to verify that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association.
This evaluation should take into account the strength of the evidence, the clinical relevance and the previous awareness of the association.
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Q: What is Validated signal?
A: A signal for which the signal validation process has verified that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association. Therefore further analysis of the signal is required. Those signals are called as validated signals.
Q: What is Non-validated signal?
A: A signal for which the signal validation process has led to the conclusion that the available documentation at that point in time does not contain sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association. Therefore further analysis of the signal is not warranted. Those signals are called as Non-validated signals.
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Q: What is Signal assessment?
A: The process of further evaluating a validated signal taking into account all available evidence, to determine whether there are new risks causally associated with the active substance or medicinal product or whether known risks have changed.
This review may include non-clinical and clinical data and should be as comprehensive as possible regarding the sources of information.
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Q: What is Refuted signal?
A: A validated signal which, following further assessment has been determined to be “false” i.e. a causal association cannot be established at that point in time. That is called as refuted signal.
Q: What is Emerging safety issue?
A: A safety issue considered by a marketing authorisation holder to require urgent attention by the competent authority because of the potential major impact on the risk-benefit balance of the medicinal product and/or on patients’ or public health, and the potential need for prompt regulatory action and communication to patients and healthcare professionals. This is called as emerging safety issue.
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Q: What is Confirmed signal?
A: A validated signal entered in EPITT that requires further analysis and prioritisation by the PRAC is called as confirmed signal.
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Q: What is Non-confirmed signal?
A: A validated signal entered in EPITT that does not require further analysis and prioritisation by the PRAC at that point in time is called as Non confirmed signal.
Q: What is Signal analysis and prioritisation by the PRAC?
A: The process by which the PRAC determines whether a confirmed signal requires further assessment, and if required, to what timeframe and in which procedural framework.
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Q: What is Signal assessment by the PRAC?
A: Following PRAC initial signal analysis and prioritisation, the process of evaluating all available data relevant to a signal to determine the need for any regulatory action.
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